Senior Quality Assurance Engineer
2 weeks ago
Ampcus is seeking an experienced Senior Quality Assurance Engineer to lead Process Validation activities in manufacturing. This role will work with cross-functional teams to determine validation activities required for projects as well as engineering and process changes.
Key Responsibilities- Support validation process through protocol drafting, approval, and execution, and provide validation training and guidance.
- Chair the Process Change Review Board and participate in Validation Review Board meetings.
- Participate in Design Transfer/Change Control projects as the Quality Assurance Core Team Lead.
- Lead improvement initiatives for Quality Assurance.
- Independently perform a full range of standard work.
- In-depth working knowledge and practical application of process validation requirements (IQ/OQ/PQ) and TMV, with ability to develop and support creation of protocols and reports.
- Proven ability to lead projects.
- In-depth knowledge of requirements related to ISO 13485 and FDA QSR.
- Strong knowledge of Risk Management and Design Controls/Design Transfer/Change Control.
- Experience with product transfers and new product development projects.
- Experience with problem-solving techniques and CAPA investigations.
- Strong organizational skills and ability to prioritize.
$90,000 - $120,000 per year, based on industry standards and location.
About AmpcusAmpcus is a leading provider of quality assurance services in the medical device industry. We are committed to delivering exceptional results and fostering a culture of excellence.
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