Supplier Quality Manager

4 weeks ago


Denver, United States EPM Scientific Full time

Summary:

The Supplier Quality Manager is essential for overseeing supplier quality interactions and ensuring compliance with Supplier Controls. This involves translating regulations and standards into company policies and procedures, and taking ownership of continuously maintaining, executing, and enhancing responsibilities within the Quality Management System (QMS). Assigned duties aim to provide exposure to engineering methods, foster independent thinking, and acquaint individuals with company practices and policies.


Job Responsibilities:

  • Leads Supplier Quality Engineering and Receiving Inspection teams, ensuring compliance with regulations and standards while overseeing detailed engineering work and inspection activities.
  • Manages supplier quality interactions, interprets regulations into company policies, and drives ongoing improvement of quality management processes.
  • Acts as an expert for regulatory/compliance issues, serves as the primary contact during audits and inspections, and facilitates supplier corrective actions.
  • Provides training and guidance to team members to ensure sufficient knowledge and execution of tasks, including approving disposition of nonconforming products.
  • Interfaces with global regulatory authorities during audits and inspections to uphold standards and compliance.
  • Develops and maintains key performance indicators (KPIs), influences quality objectives, and ensures appropriate resource allocation for business needs.
  • Provides operational leadership for the functional group's development, direction, and effectiveness, championing quality initiatives and fostering collaboration with other locations.


Education:

  • A Bachelor's degree or equivalent education and experience necessary to effectively fulfill the job's essential functions may be considered.
  • A Bachelor of Science Degree in Engineering is preferred.


Experience:

  • Minimum of 10 years of experience required.
  • Ideally, a minimum of 7 years of experience in Quality Assurance and/or Regulatory Affairs, with involvement in US FDA Class II or Class III medical devices and familiarity with global device laws and regulations.
  • At least 2 years of supervisory experience is preferred.
  • Training in FDA Quality Systems Regulation and ISO 13485 is desirable.
  • Experience with inspection methods using hand tools (such as calipers, gage pins), CMM, OGP, Keyence Optical Comparators, and Keyence Confocal Microscopes is preferred.
  • Experience in programming inspection equipment is preferred.
  • Familiarity with statistical reasoning for sampling plans is preferred.


Benefits:

  • Competitive salary range based on experience, skills, and market data alignment.
  • Target bonus on base salary to incentivize performance.
  • Comprehensive benefits package encompassing medical, dental, vision, life insurance, and retirement savings, with additional voluntary programs available.
  • Support for work-life balance through vacation and sick time programs.



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