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Quality Assurance Manager

2 months ago

Valencia, California, United States TriMed Inc Full time
Job Description

Job Summary

We are seeking a highly skilled Quality Assurance Manager to join our team at TriMed Inc. The successful candidate will be responsible for leading our Quality Management System (QMS) and ensuring compliance with regulatory requirements.

Key Responsibilities

  • Develop and implement quality policies, procedures, and processes to ensure compliance with FDA QSR, 21CFR820, ISO 13485:2016, and other regulatory requirements.
  • Lead cross-functional teams to ensure effective quality management and risk-based decision making.
  • Manage and maintain quality records, including customer feedback, complaints, and corrective actions.
  • Develop and implement training programs to ensure quality awareness and compliance among employees.
  • Collaborate with Engineering, Product Management, and Purchasing departments to ensure quality is integrated into all aspects of product development and manufacturing.
  • Provide leadership and guidance to quality staff, including coaching, mentoring, and performance management.
  • Act as the Management Representative (MR) and lead the Management Review process to ensure the QMS is suitable, adequate, and effective.
  • Support new product development and ensure quality is integrated into the product development lifecycle.
  • Monitor and analyze trends in process and product performance, including supplier performance.
  • Provide leadership in all areas of the Quality System and ensure compliance with regulatory requirements.

Requirements

  • Working knowledge of FDA QSR, 21CFR820, ISO 13485:2016, and other regulatory requirements.
  • Experience leading a team of professionals in a quality management role.
  • Excellent problem-solving, decision-making, and root cause analysis skills.
  • Bachelor's Degree in Engineering or related technical or scientific discipline.
  • 6 years' experience in quality in an FDA-regulated industry.

Working Conditions

  • This position works in an open office environment.
  • The employee is regularly required to talk or hear.
  • The employee is frequently required to stand, walk, and sit.
  • The position may require up to 20% travel.

Physical Requirements

  • The employee works in an office environment sitting for long periods of time.
  • The employee may occasionally lift and/or move up to 25 pounds.