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Manufacturing
Quality Control Systems Manager
Livonia, MI
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Orchid Orthopedic Solutions

Manufacturing Quality Assurance Coordinator

Job Description

Manufacturing Quality Assurance Coordinator Date Posted:
13 October 2026
Closing Date:
November 12, 2026
Recruiter:
Orchid Orthopedic Solutions Location:
Livonia, Michigan Salary:
USD82,000
to
USD107,000
Job Type & Industry:
Production, Manufacturing & Operations, Assurance, Quality Assurance Contract Type:
Permanent Job Reference:
3019032953-2 Apply for this job now Job Description Orchid Orthopedic Solutions seeks a Quality Coordinator to support compliant, high-precision orthopedic manufacturing. In this role, you maintain and improve the quality management system, coordinate inspections, audits, and document control, and help manage nonconformances and CAPAs. You'll collaborate with engineering, production, and supply chain teams to ensure products meet ISO 13485 and regulatory requirements, support training on quality procedures, track key metrics, and drive continuous improvement initiatives that protect patient safety and product reliability. Responsibilities Maintain and update the quality management system to meet ISO 13485 and regulatory requirements. Coordinate incoming, in-process, and final inspections for orthopedic implants and instruments. Manage document control, records, and change control for quality-related documents. Support internal and external audits, including audit preparation, execution, and follow-up. Track, investigate, and help resolve nonconformances and customer complaints. Facilitate CAPA activities using structured root cause analysis tools. Monitor and report quality metrics to identify trends and drive continuous improvement. Collaborate with engineering, operations, and supply chain to ensure product and process quality. Support training of employees on quality procedures, work instructions, and standards. Participate in cross-functional improvement projects to enhance patient safety and product reliability. Required Skills Quality management systems (QMS)
ISO 13485
compliance FDA QSR/medical device regulations Internal and supplier auditing CAPA and root cause analysis Statistical process control (SPC) Document control and record management Inspection and measurement techniques Nonconformance management ERP/MES or electronic QMS software
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