Quality Assurance Specialist

3 weeks ago


Auburn Hills, Michigan, United States Repligen Full time
Job Summary:

The Quality Control Inspector II is responsible for ensuring the quality of incoming materials and processes at Repligen. This role requires active participation in the ISO 13485 Quality Management System and involves inspecting, auditing, and reporting on various aspects of the organization's quality standards.

Key Responsibilities:

• Conduct mechanical inspections of incoming products from suppliers, including physical inspections and paperwork verification to ensure conformance to requirements.
• Utilize mechanical inspection hand tools and CMM, with FARO experience preferred.
• Perform electronics inspections to verify components against engineering records and documentation requirements.
• Identify and document inspection results, clearly communicating nonconformances to specified requirements.
• Access and interpret engineering drawings, specifications, purchase orders, and standards to determine quality status.
• Maintain accurate and timely documentation of inspection results and associated paperwork using Microsoft Office software.
• Provide QA floor support activities, including participating in cost-out activities, data collection, and maintaining quality data storage.
• Identify and communicate continuous improvement opportunities for the quality program.

Requirements:

• High School diploma or Two-year technical degree (ASME) or equivalent from an accredited technical institution is preferred.
• Minimum 3 years of experience in a quality discipline or related field, with a strong mechanical background.
• Familiarity with medical devices, bioprocessing equipment, military, or aerospace industry.
• Experience with ISO 9001, ISO 13485, AS9100, or equivalent QMS standards.
• Demonstrated use of mechanical inspection hand tools and CMM, FARO preferred.
• Basic Microsoft Office tools (Outlook, Excel, Word) and ability to read/interpret blueprints and diagrams.
• Working knowledge of GD&T and familiarity with ASME, BPE codes.
• Team-oriented with good written and verbal skills.

What Repligen Offers:

• Excellent Benefits
• Health Insurance available on day one
• 4 Competitive Medical Plan Options
• Dental, Vision, Life, and Disability Insurance Plans
• 401K
• Health Care Savings Account
• Well-being Programs
• 20 Days of PTO
• Tuition Reimbursement Program

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