Job Title

Quality assurance specialist

Location(s)

• Taiwan
• Bio Legend

About Us

Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we’re able to push boundaries in pursuit of better human health.

Find your future at Revvity

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Acts as the primary Quality Assurance contact for critical QMS processes such as non-conformances, complaint management, field corrective actions, risk management, design control, CAPA, document and change control, training, batch release, auditing and validation.
• Reviews quality records for all related areas of responsibility.
• Supervises QA personnel, including daily task management, training plans and performance management.
• Serve as qualified quality auditor for internal and supplier audits.
• Generates, reviews, approves and maintains QMS documents.
• Provides various forms of customer support (ex. Inquiry responses, customer surveys, declarations of conformity).
• Provides data for and participates in Quality Management Reviews.
• Participates in external audits (regulatory or customer) as a QMS subject matter expert and for administrative support.
• Participates in the use of the eQMS system and expanded applications as appropriate.
• This position will interact with key internal stakeholders in Manufacturing, Facilities, IT, R&D, Customer Support and Supply Chain.
• Other responsibilities as needed.
• Other projects or responsibilities as may be required.

Minimum Qualifications–Education and Experience

• Bachelors degree in scientific discipline or equivalent experience. 3 years QMS experience working in a regulated, GMP environment

Preferred Qualifications – Education and Experience

• 3 years experience in IVD, including ISO 13485:2016 and MDSAP.