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Senior Quality Assurance Engineer Role Summary
This role requires an experienced professional to oversee the quality assurance of commercial products from a design perspective. The ideal candidate will have strong technical skills and excellent analytical abilities.
- Support sustaining commercial projects, ensuring compliance with global standards throughout the product lifecycle.
- Contribute to the introduction/implementation of product/process/materials changes, assessing patient risk and providing QA technical direction/input to qualification and validation activities.
- Responsible for generating Design Verification protocols and participating in the compilation of design verification and shelf life data for regulatory submissions.
- Interface with Regulatory Affairs to ensure clear information presentation, minimizing Regulatory Agency questions.
- Maintain expert knowledge of regulatory compliance requirements and generate/approve change requests.
- Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
- Design or specify inspection and testing mechanisms, conduct quality assurance tests, and perform statistical analysis to assess non-conforming products.
- Ensure corrective measures meet acceptable reliability standards and documentation is compliant with requirements.
Key Responsibilities:
- Generate Design Verification protocols
- Participate in design verification and shelf life data compilation
- Provide QA technical direction/input
- Assess patient risk
- Collaborate with engineering and manufacturing functions
Requirements:
- Bachelor's degree and minimum 4 years relevant experience, or advanced degree with 2 years relevant experience.
- Strong problem-solving and analytical skills.
- Excellent technical writing ability.
- Applying Statistical Analysis.
- Dynamic team player with effective cross-functional collaboration.
- Good communication and fluency in English (writing and speaking).
About the Ideal Candidate:
We are seeking a highly skilled and experienced Senior Quality Assurance Engineer to join our team. The ideal candidate will have a strong background in quality assurance and a proven track record of delivering high-quality results.
