Total 199 quality assurance control job vacancies in latham new york

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.

• 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.

• 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.

• 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.

• Designs/implements/maintains a risk-based surveillance program and assessment plan associated with the quality assurance provisions of contracts.
• Identifies opportunities for process improvements by analyzing data.
• As a member of a multi-functional or technical team, implements the overall Quality Program for diverse products and services to support the U.S. Government’s acquisition at one or more supplier facilities.
• Ensures contractor compliance with design, manufacturing, repair, overhaul, and modernization requirements.
• Independently audits/surveys contractor processes to ensure compliance with customer/contractual requirements.
• Investigates customer complaints/concerns about contractor quality performance and processes which impact user satisfaction, then provides data about the complaints.
• Provides technical support to DCMA team members, assisting with analyzing contractual issues, and determining the best course of action to support the contractor and customers.

• 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 supplier’s 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 contractor’s processes to ensure customer and contractual requirements are met.
• Investigates and provides data on customer complaints/concerns regarding contractor’s 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.

• Ensure 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 applies a wide range of methods, principles, and practices related to the quality control/assurance fields such as statistical analysis, control and sampling, and 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.
• Develop and implement a surveillance plan which begins with clear objectives supported by a master schedule that includes identification of contractor and sub-contractor production needs.
• Independently perform audits/surveillance of contractor’s processes to ensure customer and contractual requirements are met.

• 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.

Job Responsibilities

• Oversee and provide guidance to QC Inspection Team to ensure implementation of all inspection-related activities according to standards, including proper disposition and handling of non-conforming material/product.

- Pre-inspection of designated goods (at warehouse).

- Sampling and QC inspection of incoming materials (pre-shipment samples, raw materials, bulk, semi-finished and finished products, packaging materials) and out-going products.

- In-process inspection to ensure that quality, hygiene, and safety standards are met.

• Identify and investigate OOS (out-of-specification) or NC (non-conformance) cases, analyse the root causes, and monitor closely the resolution and correction status.
• Investigate product feedbacks, analyse quality-related problems, and recommend problem resolution.
• Handle product stability tests.
• Work with relevant parties (e.g. external provider and product owner) to establish specifications and quality attributes of raw material, packaging and product, confirm appropriate test method for each QC parameter, and document evidence.
• Contribute for establishing and improving relevant QC SOP and inspection/testing-related work instructions (in compliance with GMP and ISO requirements).
• Ensure proper QC documentation including Master Specifications, QC Records (including electronic logs), QC Test Reports, Lab Test Reports, Non-Conformance Reports, COA etc.
• Ensure cleaning and environmental monitoring programmes for the site are done accordingly.
• Manage retention room for retention, reference and post-inspection samples, and sample retention system.

Requirements

• Degree in Science or Engineering (preferably in Cosmetic Science, Chemistry, Pharmacy, Nutrition or relevant field).
• Preferably 1-3 years of experience in the quality control of cosmetics, pharmaceuticals, dietary supplement, food, or skincare/medical device.
• Experience in a GMP environment or knowledge of GMP an important plus.
• Knowledge of relevant product standards, quality control and test methods.
• Stringent compliance to procedures, guidelines, standards, and regulations.
• Self-starter, good at working well independently with initiatives.
• Meticulous & detail oriented.
• Analytical & problem-solving skills.
• Time management skills (scheduling, prioritising) to meet deadlines.

• 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.

• 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 supplier’s 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 contractor’s processes to ensure customer and contractual requirements are met.
• Investigates and provides data on customer complaints/concerns regarding contractor’s 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.

About the Role:

This position has responsibilities for the deployment and standardization of key Quality Assurance activities including assurance of product quality, quality planning process, and maintenance of Quality Management System performance. This role will carry out responsibilities in strict adherence to regulatory requirements and applicable standards relevant to medical device, and always act with focus on quality objectives within the organization.

Roles and responsibilities:

• Functional lead for implementation, managing operational effectiveness of Complaint Handling process, trending activities, and analysis of data associated with defined KPIs.
• Responsible for monitoring and implementation escalation process and resolution for late medical device reports caused by late entries by local intake team.
• Analyze and recommend complaints received are reportable within the market, ensure adverse events reported to Authority if needed, with special attention to managing complaint-adverse event with close follow up with manufacturer and/or reporter.
• Execute, coordinate and feedback Field Corrective Action/Recalls with the countries, maintain tracking to monitor field actions in the region to ensure effective resolution or closure. Report Field Corrective Action to Authority if needed.
• Support audit readiness, conduct and prepare for regulatory/external audits as well as internal quality audits to ensure timely execution according to defined schedule.
• Participate of Nonconformity, Corrective and Preventive Actions, Documentations, Supplier Quality across the organization.
• Develop/update procedures for quality system processes to ensure alignment with Olympus global procedures as well as coordinate with other departments that effect Quality Systems.
• Provide training and support to employees concerning quality systems, policies, procedures, and core processes etc.
• Support global and local quality improvement initiatives and transformative projects.
• Execute other tasks and projects, as assigned by Manager.

About Olympus:

Our purpose at Olympus is to make peoples’ lives healthier, safer and more fulfilling. We do this through innovation. As a technology pioneer, we design and deliver solutions across our Medical division that make a positive contribution to society.

Our products are used to capture the medical and diagnostic images of our world, from the microscopic to the endoscopic. They are instrumental in furthering research, and for travelling inside the human body to help diagnose, treat and prevent illness.

Our commitment to customers and our social responsibility is the cornerstone of everything we do.

Why work at Olympus?

At Olympus, we are dedicated to fostering a high-performing culture, a collaborative environment, and enabling everyone to shine. Our common values of Patient Focus, Integrity, Innovation, Impact and Empathy, form the foundation of our culture and guide our behaviour, where our people feel like they are making a difference every single day.

Not only will you benefit from a meaningful, rewarding and challenging career, you will have access to a range of benefits:

• A competitive salary package including AWS and Variable Bonus
• Hybrid home office work arrangements
• 18 days of annual leave in your first year
• Health and Wellbeing initiatives (Annual Medical Checkups, Flu Vaccinations, Dental benefits, and Employee Assistance Programs)

What we are looking for:

• Bachelor’s degree in related field of engineering, science, or equivalent discipline.
• At least 5 years of experience working in similar position of responsibility in the medical device quality field
• Prior experience in managing quality management system in a medical device environment and quality assurance/regulatory compliance
• Must have knowledge to perform quality audit, certified auditor in ISO13485 or GDPMDS will be a plus.
• Strong knowledge of quality system requirements and medical device regulatory framework
• Meticulous and strong attention to details
• Excellent verbal and written communication skills
• Good problem solving and ability to drive change within organization
• Ability to succeed in a fast-paced, matrixed environment with speed, accuracy and adaptable to meet business need
• Positive attitude and able to work well as team player

Apply Now:

To submit your interest in this opportunity, select “Apply for this job”.

In the meantime, follow us on:

• LinkedIn - Olympus APAC
• Company website - www.olympus.com.sg

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.

Job Responsibilities

• Work closely with all production team on the production process and oversee the day-to-day operations to ensure compliance with AVA, NEA HACCP guidelines and ISO standards
• Perform the creation and revision of corporate level quality documents that support GMP operations to ensure compliance with GMP guidelines
• Assist to contribute to the maintenance and continuous improvement of the Record Management systems and processes
• Assist to conduct regular risk assessment of corporate compliance against ever-changing Food Safety regulation to identify and work with relevant technology to develop mitigation plan
• Assist to develop Food Safety and Food Defends related standards
• Assist to develop Food Safety and Food Defends training materials
• Assist in driving the implementation of the Food Safety and Food Defends system and prerequisite program ingredient
• Conduct impact assessments and updates to QMS policies
• Manage QMS Management Review meetings according to local SOPs
• Maintain ISO / HACCP documentation and monitoring records update
• Handle all related operations audits
• Work closely with Marketing/ Sales and Production in packaging artwork development by providing product technical information eg. ingredient listings, nutrition labels that comply with labelling regulations of sales countries
• Update internal and external customers on the status of the quality issues
• Assist to ensure appropriate corrective and preventive actions are taken to eliminate detected non-conformance and the causes
• Provide Technical support to Marketing, R&D, Sales & Operations and Business Development teams in terms of product information enquiries from customers and country customs
• Other duties as assigned by the Head of Department

Job Requirements

• Able to communicate with all level and good interpersonal skills
• Knowledge in food labelling regulatory requirements pertaining to product claims, ingredient listing, nutrition labelling and etc.
• Meticulous with good attention to details and an effective change agent

Education, Experience & Training

• Min. Diploma/Degree in Food Technology, Food Science or its equivalent qualifications
• At least 1 year of experience working in SME food manufacturing environment
• With minimum 2 years in Quality Assurance or Quality Management, preferably in Food Industry
• Knowledge of HACCP, ISO22000 & GMP requirement will be advantage

• At the full performance level (GS-11), the incumbent will have the following duties:
• Negotiating differences in scope, direction of change, and costs of labor, materials, equipment, overhead, etc., at issue with the contractor.
• Reviews contractor's proposal against prepared government estimate.
• Responsible for evaluating its design feasibility and cost effectiveness.
• Conducting any necessary coordination with project personnel, using agency representatives, District personnel .
• Provide comprehensive advisory and technical services on functions and practices to all other members of the assigned program or project team.
• Provide comprehensive management advisory and technical services to investigate the need for contract change orders.
• Prepares documentation of contract modifications.