Quality Manager Job at G&H Staffing Companies (Temp-Secure Staffing and LSE Staffin..., Leominster, MA

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  • G&H Staffing Companies (Temp-Secure Staffing and LSE Staffin...
  • Leominster, MA

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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