Total 272 quality assurance control job vacancies in hong kong central

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.

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.

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

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

You’ll get to:

• As a Quality Engineer, you have the opportunity to accelerate the delivery and to improve the quality of the software we build through recommending and implementing automated test suites.
• Work with vendors, government agencies and teams to identify end-to-end test scenarios as well as to automate these test scenarios, applying risk-based strategy to minimize manual interventions.
• Analyse and decompose complicated software systems and design a strategy to test these systems.
• Review Quality Assurance Plan and Test Strategy to provide timely and meaningful feedback.
• Ensure all required testing documentations are in place as part of production preparation checks.
• Drive and advocate continuous improvement in testing practices and tools.
• Conduct research on emerging test automation technologies that can optimize and accelerate the project delivery.

What you’ll bring to the team:

• Degree or Diploma in Computer Science, Computer or Electronics Engineering, Information Technology, or related disciplines
• Minimum 5 years' experience in application exploratory testing and regression test automation, application performance testing, and/or application security testing. Hands-on experience in automating various types of tests such as unit tests, API tests, Integration Tests, UI Tests, and End-to-end Tests.
• Create and support test automation strategies and implementations
• Knowledge of test best practices, test methodologies and their corresponding tools.
• Must have strong troubleshooting and debugging skills
• Meticulous attention to details
• Strong analytical, interpersonal and presentation skills
• Keen to share knowledge with team mates
• Curious, open to new ideas
• Quick to learn new skills
• Proactive, self-driven and motivated

Bonus points for:

• ISTQB, CSQA, CSTP or other relevant certification
• Excellent verbal communication and listening skills
• Experience in agile development environment will be an added advantage
• Experience in DevOps will be an added advantage
• Experience in Performance testing will be an added advantage