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Orchid Orthopedic Solutions

Quality Assurance Coordinator - Medical Device Manufacturing

Pay: Not specified

Posted: 3 weeks ago

Location: Birmingham, MI (Onsite)

Last Updated: 2 weeks ago

Hours: Full-Time

Expires: 11/14/2026

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Job Description

Quality Assurance Coordinator -

Medical Device Manufacturing Date Posted:

13 October 2026

Closing Date:

November 12, 2026

Recruiter:

Orchid Orthopedic Solutions Location:

Birmingham, Michigan Salary:

USD74,000

USD92,000

Job Type & Industry:

Production, Manufacturing & Operations, Assurance, Quality Assurance Contract Type:

Permanent Job Reference:

3019033408-2 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. In this role, you will coordinate inspections, maintain quality documentation, and support internal audits in a regulated ISO 13485 and FDA QSR environment. You will investigate nonconformances, help drive CAPA and continuous improvement initiatives, and collaborate with engineering, operations, and support teams across sites. This position offers structured training, exposure to advanced manufacturing, and the chance to directly impact patient outcomes through quality and safety. Responsibilities Coordinate in-process and final inspections for orthopedic implants and instruments Maintain and update quality documentation, records, and reports Support compliance with

ISO 13485, FDA

QSR, and internal quality procedures Assist with nonconformance investigations and CAPA activities Participate in internal audits and support external audits as needed Collaborate with engineering and operations to address quality issues Monitor quality metrics and support continuous improvement projects Ensure accurate use and calibration of inspection and measurement tools Required Skills Quality management systems (ISO 13485) FDA QSR/medical device regulatory compliance Inspection and measurement tools Statistical process control (SPC) Root cause analysis & CAPADocument control and recordkeeping Nonconformance investigation Internal auditing Reading engineering drawings & GD&TMicrosoft Office/ERP or MES systems