Senior Quality Assurance Engineer

4 weeks ago


Westborough, Massachusetts, United States Olympus Full time
Job Description

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.
Requirements
  • 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.
Why Work at Olympus?

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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