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Quality Control Systems Manager
Farmington, MI
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Now viewing: Quality Assurance Coordinator - Medical Device Manufacturing
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Orchid Orthopedic Solutions

Quality Assurance Coordinator - Medical Device Manufacturing

Job Description

Quality Assurance Coordinator -
Medical Device Manufacturing Date Posted:
13 October 2026
Closing Date:
November 12, 2026
Recruiter:
Orchid Orthopedic Solutions Location:
Farmington, Michigan Salary:
USD82,000
to
USD108,000
Job Type & Industry:
Production, Manufacturing & Operations, Assurance, Quality Assurance Contract Type:
Permanent Job Reference:
3019033003-2 Apply for this job now Job Description Orchid Orthopedic Solutions seeks a Quality Coordinator to support compliant, high-precision manufacturing of orthopedic implants and instruments. You will coordinate inspections, maintain quality records, and ensure adherence to ISO 13485, FDA, and customer requirements. Responsibilities include reviewing batch documentation, managing nonconformances, supporting CAPA and root cause analysis, and collaborating with production and engineering. You'll help drive continuous improvement, support audits, and reinforce a safety- and patient-focused culture in a regulated medical device environment with strong training and development. Responsibilities Coordinate in-process and final inspections for orthopedic components and assemblies. Maintain accurate quality documentation, batch records, and device history files. Ensure compliance with
ISO 13485, FDA
QSR, and customer quality requirements. Support nonconformance investigations and manage defect documentation. Assist with root cause analysis and CAPA implementation. Collaborate with production, engineering, and supply chain to resolve quality issues. Monitor quality metrics and support continuous improvement initiatives. Prepare for and support internal, customer, and regulatory audits. Train operators on quality procedures and inspection standards. Promote a culture of safety, integrity, and patient-focused quality. Required Skills Quality Management Systems (QMS)
ISO 13485/ISO 9001 GMP/FDA QSR
compliance Root cause analysis Corrective and Preventive Actions (CAPA) Statistical process control (SPC) Quality documentation and recordkeeping Inspection and measurement tools Nonconformance management Internal auditing
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