Total 49 Quality Assurance / Control job vacancies in New Cumberland Defense Logistics Center, Pennsylvania

This is an OPEN CONTINUOUS ANNOUNCEMENT and will remain open until December 12, 2024. The initial cut-off date for referral of eligible applications will be November 19, 2024, with subsequent cut-off dates on Tuesday of each remaining week. This announcement may be extended or removed from USAJobs.gov at any time.

Total-Rewards-of-an-Allied-Health-VA-Career-Brochure.pdf

Medical Supply Aide and Technician: vacareers.va.gov/wp-content/uploads/sites/5/Total-Rewards-of-a-

The VA Bronx Healthcare System provides outstanding health care, trains America's future health care providers, and conducts important medical research. We provide health care services at 4 locations in Bronx, northern Queens, and Westchester counties. Facilities include our James J. Peters VA Medical Center and 3 community-based outpatient clinics in Queens, White Plains, and Yonkers.

The VA Bronx Healthcare System is one of the leading health care systems serving Veterans in the New York/New Jersey VA Health Care Network. We're an innovative care center within the Veterans Integrated Service Network 2 (VISN 2), which includes medical centers and clinics in New York, New Jersey, and Pennsylvania.

The Medical Supply Technician (Sterile Processing) - QA serves as the monitoring/Tracking specialist for all activities of SPS, which includes the operating room case cart management system. The major duties and responsibilities of this position include but are not limited to:

• Monitors the process of cleaning/decontamination, sterilization, reprocessing, and distribution of critical, semi-critical and non-critical Reusable Medical Devices (RMD). This includes following the use of bacteriological controls, principles and methods of sterilization, packaging, and assembly of simple to more complex items for therapeutic and surgical procedures.
• Develops procedures to evaluate the quality of work performance and outcomes as it relates to the quality assurance program.
• Maintains a system of internal and external reviews ensuring overall compliance of all critical, semi- critical and non-critical RMD used within the medical center.
• Tracks and analyzes required documentation pertaining to critical, semi-critical and non-critical RMD within the scope of SPS for quality control purposes.
• Utilizes qualitative analysis tools to prepare reports for trending, evaluate operations and facilitate improvements in workflow and quality processes.
• Troubleshoots computer programs related to SPS operations and trains staff on the inputting of data associated with the cleaning and sterilization of equipment, biological processing, and quality assurance programs.
• Collaborates with SPS management when deviations occur.
• Validates SPS policies on cleaning and sterilization as it relates to manufacturer information for use, standards, and mandates.
• Updates the quality assurance program annually or when manufacturer information and guidelines are changed.
• Uses instrument marking techniques for the proper identification and tracking of surgical instrumentation after sterilization. Marks existing and new instruments and uploads to CensiTrac
• Maintains records produced by automated equipment tracking systems.
• Demonstrates high proficiency in computer programs as they are responsible for providing expertise, guidance, and training, when necessary, for and to the staff and management of the Sterile Processing Service on the automated equipment tracking system and its interconnection with the Case Cart, Decontamination and Preparation areas.
• Demonstrates competency in and uses automated equipment tracking systems to plan for and determine current and future supply and instrument requirements to meet the needs of the facility.
• Utilizes and is proficient in electronic equipment tracking systems and data communication systems and is required to remain up to date as technology changes and improvements to systems are made.
• Reviews data and validates information, develops templates for reporting purposes, analyzes data for performance improvement.
• Monitors the quality of input and output of automated inventory management systems, recommends system and program changes to improve timeliness, accuracy, and utility of inventory information for users.
• Participates in the installation of automated instrument tracking systems in SPS by defining the nature of information required, organizational responsibilities, computer network requirements, and the nature of output from the service.
• Demonstrates competency in and uses various instrument marking techniques for the identification of instrumentation and utilizes the appropriate technique for the instrument composition and use.

Major Duties:
This position is located in the Office of the Director of a local health care system and reports to the Medical Center Director. Duties include, but may not be limited to the following:

• Developing, recommending, and implementing Compliance and Integrity program goals for operational units within the local health care system.
• Developing detailed plans, tasks, milestone dates and schedules to ensure proper sequencing of events and tracking of processes and costs throughout the life cycle of the programs/projects.
• Participating in regular information planning sessions, maintain productive interaction with staff, report on the status and progress of work accomplished to date, and monitor work in progress.
• Exercising oversight of implementation of the Compliance and Integrity program within the local health care system to ensure it is effective.
• Implementing national Compliance and Integrity controls/audits, solutions, and programs at the local health care system.
• Developing and implementing internal controls and solutions, in partnership with risk owners, to manage and mitigate key risks that may adversely impact local health care system objectives, compliance with regulations, or overall reputation within the local, VISN, or national landscape of the agency health care system.
• Establishing and maintaining the "tone at the top" within the local health care system for Compliance and Integrity.
• Providing regular communications to local health care system staff on the importance of Compliance and Integrity.
• Drafting guidance and direction regarding program management and reporting.
• Performing local health care system-wide reviews of internal controls over prioritized risk areas and determine adequacy in preventing compliance failures.
• Participating in meetings with internal staff and representative operational units within the local health care system to determine compliance program status, major milestones, and coordination of each to detect in advance potential slippage or increased costs.
• Understanding local strategy, local needs, and risks of the local health care system.
• Analyzing and prioritizing local risks by working closely with senior management to develop a proactive strategy to mitigate compliance risks.
• Performs other related duties as assigned.

Work Schedule: Monday-Friday, 8:00am to 4:30pm, subject to change based on the needs of the Facility
Telework: VA supports the use of telework as a way to help attract and retain talented individuals in public service, increase worker productivity, and better prepare the agency to operate during emergencies. This position may be authorized for telework. Telework eligibility will be discussed during the interview process.
Virtual: This is not a virtual position.
Position Description/PD#: Health System Specialist - Integrity and Compliance Officer/PD99467S
Relocation/Recruitment Incentives: Not authorized
Critical Skills Incentive (CSI): Not approved
Permanent Change of Station (PCS): Not authorized
Financial Disclosure: Required

As a Program Operations Assistant you will:

• Serve as organizational point for the administration and maintenance of several integrated electronic administrative management tracking systems.
• Receive, read, and prepare responses to incoming correspondence as requested based upon content and topic.
• Perform administrative duties for seminars, small work groups, and conferences that involve Center staff.
• Serve as time clerk for the Branch and/or Team and back-up to the official Division timekeeper as needed, and as such is responsible for the electronic processing and transfer of time and attendance records using the CDC/IS mainframe system.
• Receive and answer telephone and personal inquiries from officials within CDC, DHHS, other Federal agencies, members of Congress, state agencies, foreign visitors, and national organizations.

• Ensures contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Applies a wide range of methods, principles, and practices directly related to quality control/quality assurance fields; statistical analysis, control and sampling, quality data analysis and evaluation to determine contractor compliance.
• Incorporates a thorough and detailed QA knowledge in applying various methods and techniques for investigating, analyzing, and ensuring corrective action on complex quality problems.
• Develops and implements a surveillance plan which begins with clear objectives supported by a master schedule that includes identification of contractor and sub-contractor production needs.
• Performs audits/surveillance of contractor’s processes to ensure customer and contractual requirements are met.

• Performs duties associated with the administration of the quality assurance provisions of contracts by designing, implementing, and maintaining a risk-based surveillance program and assessment plan.
• Identifies opportunities for process improvements through analysis of process measurement data. Serves as a member of a multi-functional or technical team.
• Responsible for implementing the overall Quality Program for a diversity of products and services in support of U.S. Government acquisition at one or more suppliers facilities.
• Ensures contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Independently performs audits/surveillance of contractors processes to ensure customer and contractual requirements are met.
• Investigates and provides data on customer complaints/concerns regarding contractors quality performance and processes which impact user satisfaction.
• Provides technical support to all other DCMA team members, assisting in the analysis of contract related issues to determine the best course of action to support the contractor and customers.

• Responsible for a wide range of technical and quality activities within the Technical/Quality Division of the Directorate
• Responsible for planning, organizing, coordinating, directing, and integrating the work of subordinate staff.
• Manages and directs subordinate technical, quality assurance and administrative personnel.
• Develops, presents, and promulgates recommendations for changes in/enhancements to branch programs to improve customer service and satisfaction.
• Manages studies and special projects regarding and affecting Supplier Operations plans, goals and initiatives.
• Monitors the collection, consolidation and analysis of metrics and data used to inform operating officials regarding the viability, effectiveness, and efficiency of Team programs.
• Identifies and implements initiatives to eliminate or reduce inefficient and/or ineffective work practices and provides technical guidance to subordinates to improve efficiency and productivity.
• Reviews decisions made by subordinates and/or team leads, assuring application of all personnel management programs.

The primary purpose of this position is: To provide visual flight rules (VFR) air traffic control services to aircraft operating in the vicinity of an airport or on the controlled movement area of the airfield, providing for the safe, orderly, and expeditious air traffic flow.

• Controls military and civilian aircraft under visual flight rules (VFR) in a control tower environment
• Observes and reports airport advisories, critical weather information, and equipment outages
• Provides instruction and assistance to air traffic control personnel
• Maintains certification requirements

Supervises a staff of Air Traffic Control Specialists that is responsible for carrying out air traffic control assignments within a geographic area.

Plans and assigns work to be accomplished by subordinate employees. Sets work priorities and schedules. Approves leave; gives advice, counsel, and instruction to employees on both work and administrative matters. Evaluates performance of employees and recommends performance ratings. Hears and resolves complaints from employees and refers group grievances and more serious unresolved complaints to a higher level manager. Identifies and arranges for developmental and other training needs of employees. Finds ways to improve production or increase the quality of the work directed. Adjusts staffing levels and work procedures to accommodate resource decisions made at higher levels. Recommends goals and objectives for the area and tracks accomplishments.

Communicates and reinforces diversity and EEO policies and programs in all areas of responsibility, including selections, training, and transfers. Supports and participates in the labor management partnership process, and fosters a work environment where all employees are treated in a fair and equitable manner.

The Operations Supervisor reports to the Operations Manager. Performance is evaluated upon the effectiveness with which assigned program objectives are achieved.

• Contribute senior leadership and participates in regional business processes such as strategic planning, workload sharing, and quality management for engineering and construction.
• Serve as Division senior technical advisor to the districts in their discipline on engineering activities, responsible for the competence of projects designed and built in the Division.
• Provide leadership for solutions of advanced, unprecedented engineering problems to key managers, counterparts at the districts, higher headquarters, Corps research and development laboratories, and other Corps, government, and private interests.
• Participate in Regional and national-level meetings, workshops, committees, professional conferences, inter-agency panels, and boards for exchange of technical information and advice on matters regarding engineering.

About HOYA Surgical Optics (HSO)

HOYA Surgical Optics (HSO) is the globally leading Preloaded Intraocular Lens (IOL) focused company that provides technologies and solutions that exceed expectations, enabling ophthalmic surgeons to focus on restoring sight. We are dedicated to improving the vision and quality of life for millions of people suffering from cataract, and helping them celebrate life visually.

HSO empowers cataract surgeons all over the world with innovative ophthalmic devices and services, with an attention to detail that helps them achieve better surgical outcomes and better practice results. Our commitment to delivering these results is grounded upon a quality management system that is continuously improving to meet changing global regulatory requirements and our entrepreneurial drive to be the brand of first choice.

At HSO, People is the key factor to our success. We aim to create a conducive work environment for our employees around the globe, and to promote an inclusive culture based on our core values – Excellence, Passion, Innovative, Collaboration, and Accountability.

HSO way of working

In fulfilling our roles, we are

• Accountable for our own capabilities and development,
• Focused on delivering results without excuses, and
• Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.

We are looking for people who

• See beyond themselves and are impact-focused,
• Consider the needs, challenges, and objectives of every person with whom they interact, and
• Exhibit positive reinforcement to help others succeed.

About the role

Works closely with and have impact on: Global Quality Assurance Team

Reports to: Senior QA Engineer

Function: Global QA

Work Location/Site: Singapore / GHQ

Internship Duration: Any 3 months between January to May 2025

Role Overview

The QA intern will support the quality and various project teams with validation needs in MasterControl, our cloud-based Quality Management System (QMS) for HSO.

Duties and Responsibilities

• Assist to perform validation duties to ensure software validation project and corresponding deliverables adhere to current regulations and quality standards
• Actively contribute towards continuous improvement of the quality team by suggesting new ideas and promoting innovative culture through improving and optimizing analysis of quality data and process workflows
• Provide support to record management and archiving activities
• Support post-migration and improvement activity works for the QMS
• Assist with QMS Modules improvement and maintenance activities
• Participate in team activities and initiatives related to QMS and regulatory requirements
• Other duties as assigned

Requirements

Experience

• N/A

Skills/Accreditations

• Microsoft office skills essential. Candidates with Excel Macro skills preferred
• Some Quality system knowledge will be advantageous
• Self-awareness and Good work ethics
• Strong communication and interpersonal skill

Academic Qualifications

• Pursuing Diploma or Degree Preferably in Science or Engineering

Travel requirements

• N/A

By submitting your application, you agree that your personal data will be collected, disclosed, and retained by HOYA Group for assessing suitability for employment and verification purposes.

We regret to inform you that due to the number of applications received, only shortlisted applicants will be notified. Thank you for your kind understanding.

About HOYA Surgical Optics (HSO)

HOYA Surgical Optics (HSO) is the globally leading Preloaded Intraocular Lens (IOL) focused company that provides technologies and solutions that exceed expectations, enabling ophthalmic surgeons to focus on restoring sight. We are dedicated to improving the vision and quality of life for millions of people suffering from cataract, and helping them celebrate life visually.

HSO empowers cataract surgeons all over the world with innovative ophthalmic devices and services, with an attention to detail that helps them achieve better surgical outcomes and better practice results. Our commitment to delivering these results is grounded upon a quality management system that is continuously improving to meet changing global regulatory requirements and our entrepreneurial drive to be the brand of first choice.

At HSO, People is the key factor to our success. We aim to create a conducive work environment for our employees around the globe, and to promote an inclusive culture based on our core values – Excellence, Passion, Innovative, Collaboration, and Accountability.

HSO way of working

In fulfilling our roles, we are

• Accountable for our own capabilities and development,
• Focused on delivering results without excuses, and
• Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.
• We are looking for people who
• See beyond themselves and are impact-focused,
• Consider the needs, challenges, and objectives of every person with whom they interact, and
• Exhibit positive reinforcement to help others succeed.

About the role

Works closely with and have impact on: Global Research & Development (R&D), Post Market Surveillance, and Global Regulatory Affairs (RA) Teams

Reports to: Senior Manager QA R&D

Function: Global QA & Compliance Organization

Work Location/Site: Singapore / Global Headquarters

Role Overview

This position is responsible to ensure that products meet quality goals and regulatory requirements, including but not limited to FDA Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971 and maintain compliance of the Quality Management System (QMS).

Duties and Responsibilities

• Partner with R&D teams in the USA, Japan, and Singapore to ensure that design control is completed in accordance with procedures, WI, regulatory requirements, and assure that required outputs have been completed
• Execute risk management for devices, processes, and provide the assessment results from product development through to the launch
• Maintain and update risk management files with Global R&D/Manufacturing Engineering (ME) teams to support product development (Risk Management Plans, Risk Control Log, Benefit Risk Assessment Risk Management Report, xFMEA, etc.), and act as the Risk Management expert
• Assist in the review and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports, and design transfer
• Review and approve design verification test protocols, reports and data from a logical point of view (Compliance, rationale, objectiveness and statistics)
• Partner within Quality and R&D to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met
• Review and approve biocompatibility protocols and reports
• Ensure compliance of IQ, OQ, tests method validation, Standard Operating procedures and work instructions regarding product development
• Maintain compliance to QMS procedures of the R&D Singapore site, and support the Singapore R&D Site - QA
• Support External audits by competent authorities and notified bodies
• Support internal audits at the local site, and other sites as required
• Review and approve other quality documents (e.g., IQ, OQ, PQ, WI, etc) within areas of responsibility
• Propose and execute quality/process improvements. Write/review policies/ processes/ procedures and related documents
• Manage and monitor the progress of the calibration and maintenance of testing equipment. Ensure calibration or maintenance records satisfy regulatory and QMS requirements (act as Equipment Control Administrator in Singapore)
• Participate in development projects and change control request meetings to support the resolution of engineering issues
• Collaborate with the post-market surveillance team and complaints investigation teams to maintain risk management process throughout a product’s lifecycle
• Provide support for other quality activities and improvement initiatives, quality data collection and trending, CAPAs, change controls, training, etc.
• Support initiatives as identified by management to support QMS and other regulatory requirements in Singapore

Requirements

Experience

• At least 4+ years of Industry experience working as QE Engineer in Medical Device/ Pharmaceutical product or optical engineering business field
• Experience in test method validation
• Experience in Design control, Design Transfer, Design and Development Process
• Demonstrated knowledge of Risk Management (ISO14971), Design control, Design and Development Process and Quality System (any one of ISO13485).
• Understanding and Knowledge of biocompatibility studies
• Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills
• Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation). Practical experience in design control and risk management
• Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues
• Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities
• Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required
• Capable of clearly presenting and justifying quality requirements to management
• Accreditation by a professional body is highly desirable. Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)

Skills/Accreditations

• Smooth communication ability
• Business software skills (e.g. Word, Excel and Power point)
• Experience with statistical software such as Minitab
• Voluntary working attitude with a creative idea
• Passionate working attitude to pursue a goal with patience.
• Flexibility for changes

Academic Qualifications

• A bachelor’s degree or higher in Chemical, Bioengineering, Mechanical, Optical Engineering or related fields.

Travel requirements

• 2-3 international travel annually mainly Thailand.

By submitting your application, you consent to HOYA Group collecting, disclosing, and retaining your personal data for employment assessment and verification purposes.

If you are shortlisted, we will contact you within three weeks of your application. Thank you for your application and understanding.

Job Duties:

• Manage the process for QMS audits, to ensure compliance of the organization’s Integrated Management Systems wrt ISO9001/TS16949/ VDA 6.3, Customer specific requirements.
• Identify areas/ system gaps for improvement and implementation. Establish and drive QMS enhancement and integration roadmap/milestones.
• Work closely with Operations and key stakeholders to maintain consistent manufacturing, quality policies and compliance
• Responsible for maintaining/improving fab performance though SPC program.
• Investigate root causes and resolve key fab-related quality issues and effectiveness of corrective and preventive actions. Manage Non-Conformance cases with respect to on-time closure with the relevant customers/Business Lines.
• Responsible for Outgoing and Periodic review OQA performance to drive defect reductions
• Responsible for Document Centre Management & Library Services
• Management of change among diverse cultures in a fast paced environment
• Co-work with related functions to support the wafer fabrication process to drive process/system optimization and effectiveness

Job Qualifications:

• Degree in Chemical / Electrical Engineering / Physics / Chemistry or equivalent
• 8+ years in semiconductor industry preferred
• Knowledge of wafer fabrication process essential
• Strong in project management skills, facilitation, analytical skills and system thinking

• Serve under the general supervision of the Supervisory Fire Inspector (Captain), who makes assignments based on the overall policy and general content of the fire prevention program.
• Operate within an assigned inspection area to include high-risk, conducting comprehensive fire/safety inspections to identify and correct hazardous conditions.
• Identify complex unique hazards and devises corrective measures.
• Conduct public education classes post-wide as well as on-the-job training classes for fire department personnel.
• Provide training in general fire/safety subjects as well as issues unique to a particular activity.
• Conduct review of architectural drawings and specifications to determine compliance with fire/safety regulations and evaluates special features impacting the fire protection mission.
• Respond to emergency incidents as part of a firefighting team, performs a full range of firefighting duties at all types of emergency incidents, maintaining a degree of firefighting proficiency sufficient to perform firefighting tasks.

• Advises on, integrates, monitors and/or performs duties concerned with the Safety, Reliability, Quality and Mission Assurance disciplines for Launch Vehicles managed by the Launch Services Program.
• Responsible for integration and coordination of all independent mission assurance flight readiness aspects for assigned missions; ensuring mission unique hardware, first flight items, and launch vehicle hardware anomalies are evaluated and assessed.
• Maintains cognizance of launch vehicles from mission launch vehicle selection through launch campaign activities and integrated vehicle/spacecraft operations.
• Reviews mission products and advises the Launch Services Program and Technical Authorities on the appropriate mission risk above the baseline (residual risk) for the launch vehicle; Ensures sufficient risk acceptance rationale exists.
• Supports the launch countdown, providing recommendations on any anomaly resolutions and presenting the go/no-go position to SMA management, and ensures acceptable resolution for any post flight anomaly observations.
• Serves on panels/committees and working groups responsible for conducting detailed technical/programmatic independent assessments on vehicle systems and fleets.
• Evaluates and integrates mission related assessments and reviews and keeps the Directorate informed of progress and unusual issues/concerns.
• Fosters a culture of engagement, diversity, inclusiveness, excellence and innovation. Champion NASA's commitment to Diversity, Equity, Inclusion and Accessibility to create an environment that promotes a commitment to safety, integrity, and teamwork.

• If selected at the GS-11 level, duties will be performed in a developmental capacity.
• Plans/executes engineering and technical functions related to engineering, manufacturing, and quality assurance.
• Develops and/or implements agency engineering and quality assurance policies, tools, and training program.
• Provides authoritative guidance and advice to management, customers, and Quality Assurance Specialists in functional area of expertise.
• Resolves complex technical problems associated with surveillance of major, critical contracts for program life cycle stages, next generation equipment, or DoD Weapon Systems.