Job Description

Our client is looking for a Quality Manager. This is a direct hire opportunity.

Responsibilities

• Develop standardized production, quality, and customer-service standards
• Evaluate production operations to ensure that products meet quality, integrity, functionality, and other specifications and requirements.
• Ensure the effective use of QMS systems including CAPAs, customer complaints, NCRs/MRB, change management, training, supplier management, deviations, preventive maintenance, and calibration.
• Implement Quality Control objectives, metrics, KPIs, and reporting to monitor production quality and post-sale product performance and identify continuous improvement opportunities.
• Ensure departmental compliance with the QMS, FDA QSR, ISO13485, ISO9001, and other regulatory requirements.
• Prepare product and process quality reports by collecting, analyzing, and summarizing information and trends.
• Monitor supplier performance; evaluate and improve supplier auditing and monitoring processes.
• Oversee internal quality audits and develop corrective action plans to address findings; support external audits

Qualifications

• 5+ years of experience in quality management in process-oriented manufacturing operations in a regulated environment, with a minimum of 3 years in managing quality control/management.
• Minimum 2 years of experience in medical devices and FDA QSR and ISO 13485 required; prior defense/aerospace industry experience desired.
• Demonstrated experience in implementation and continuous improvement of the QMS to improve quality, reduce costs and improve efficiency.
• Lean and/or Six Sigma certification/experience highly preferred.

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