Job: Quality Specialist (Medical devices) – Canton

Opportunity

Our client, a leader in providing blood management, cardiovascular, and unique critical care medical devices, is seeking a Quality Specialist to join their team in Canton, MI. The ideal candidate will support the Quality Management System in the establishment and implementation of quality systems in accordance with cGMPs, applicable CFR requirements, ISO 13485, and FDA expectations. The Quality Specialist creates and updates SOPs and Work Instructions, documents and investigates customer complaints, performs receiving and inspection activities, and performs supplier qualification assessments.

Responsibilities

• Represent the organization as a primary contact for specific projects and initiatives and communicate with internal and external customers and suppliers at various levels
• Use project management tools in documenting timelines, building action items lists, and assigning responsibility and completion dates
• Generate and review new and revised quality documents (SOPs, quality forms, Device Master Records, DCRs)
• Perform supplier qualification assessments
• Perform incoming receiving and inspection activities
• Lead failure investigations and root cause analysis in support of the medical device complaint handling process
• Train other team members on Good Manufacturing Practices
• Interface with regulatory and notified body auditors

Qualifications

• Bachelor’s Degree in Science or Engineering preferred; equivalent work experience considered
• 3+ years of experience in a Quality Department role in the medical device or pharmaceutical industry
• Experience with the following is preferred:
  • CAPA systems
  • Root Cause Analysis (RCA)
  • Customer Complaints
  • ISO 13485
  • 21 CFR 820
• Excellent problem-solving and analytical skills
• Able to organize and lead project teams of up to 10 people
• Work well under time pressure

Benefits

• Pay is commensurate with experience
• Business casual dress code
• Full suite of benefits offered

Apply

If your skills match the requirements for this challenging opportunity, please send us your resume today.

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