Senior Quality Assurance Engineer
4 weeks ago
The Senior Supplier Quality Engineer is responsible for ensuring the quality of products sourced from suppliers within a defined material segment and site. This includes part approval, SCAR handling, development project support, sustaining engineering support, non-conformance handling, and incoming inspection planning.
Key Responsibilities- Develops quality assurance strategies for sourced products in collaboration with Manufacturing Quality Assurance.
- Acts as the supplier quality engineering representative in new product development projects.
- Performs Advanced Product Quality Planning (APQP) by applying appropriate methods, including early supplier involvement in development projects, and ensures that required process validations are sufficiently implemented.
- Coordinates and ensures the effectiveness of the external component qualification/FA process.
- Identifies gaps in suppliers' capabilities and technical project risks.
- Accountable for incoming inspection planning.
- Makes decisions on the acceptance or rejection of sourced materials.
- Guides inspectors regarding incoming inspections, including training, standards, and best practices.
- Responsible for the SCAR process as part of the non-conformance process.
- Leads improvement projects at the supplier level.
- Acts as the primary interface to suppliers regarding product-related quality matters.
- Analyzes product-related supplier quality issues.
- Participates in material review boards.
- Supports facility audits by outside agencies, such as FDA and ISO/MDSAP.
- Supports supplier audits as a co-auditor.
- Performs local supplier management, including supplier approval, auditing, QAA negotiation, and supplier evaluation, if delegated by SQM.
- Minimum requirements include a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree.
- Minimum of 5-10 years of experience in a related field.
- Very good knowledge of quality tools and methods.
- ISO 9001, FDA, and Medical technology background.
- Basic project management skills.
- Advanced English language skills.
- 20% travel is expected.
Olympus offers a holistic employee experience that supports personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
We provide:
- Competitive salaries, annual bonuses, and 401(k) with company match.
- Comprehensive medical, dental, and vision coverage effective on start date.
- 24/7 Employee Assistance Program.
- Free live and on-demand Wellbeing Programs.
- Generous Paid Vacation and Sick Time.
- Paid Parental Leave and Adoption Assistance.
- 12 Paid Holidays.
- On-Site Child Daycare, Café, Fitness Center.
We strive to create a work-life integrated culture that supports an employee-centric mindset, offers onsite, hybrid, and field work environments, and provides opportunities for professional growth and development.
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