Quality Engineering Manager

$134,763 - $134,763/Yr

Olympus - San Jose, CA

posted 4 days ago

Full-time - Manager
San Jose, CA
5,001-10,000 employees
Merchant Wholesalers, Durable Goods

About the position

The Quality Engineering Manager at Olympus is responsible for overseeing the management of Quality Engineers, ensuring compliance with regulatory requirements, and leading quality projects. This role involves providing leadership and guidance, managing the execution of activities to meet quality standards, and supporting operations in the processing of medical devices. The position reports to the Director of Quality, San Jose Operations.

Responsibilities

  • Oversee management responsibilities for Quality Engineers, including leadership and guidance.
  • Manage the execution of activities to ensure compliance with OSTA and local Quality Systems.
  • Lead Quality Projects and Corrective and Preventive Actions (CAPAs).
  • Support and lead Change Orders as needed.
  • Promote awareness and compliance with Quality and Regulatory requirements across the site.
  • Ensure effective and efficient inspections occur.
  • Manage calibration for equipment used by the site.
  • Ensure Preventive Maintenance activities are performed for Quality equipment.
  • Manage audit preparedness, including internal and third-party audits.
  • Responsible for compliance of the Non-Conformance Report (NCR) process.
  • Lead Material Review Board (MRB) to ensure proper disposition of non-conforming products.
  • Provide metrics for management review regarding quality systems.

Requirements

  • A 4-year degree in Engineering or related science.
  • Minimum of five years experience in the Medical Device industry with responsibility for product quality and compliance.
  • Familiarity with U.S. FDA QSR, ISO 9001, MDD 93/42, and ISO 13485.

Nice-to-haves

  • Strong working knowledge of problem-solving skills.
  • Excellent verbal and written communication skills, including the ability to generate technical reports and make presentations.

Benefits

  • Competitive salaries, annual bonus, 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.
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