Associate Manager, Quality Assurance Job at Stryker, Irvine, CA

  • Stryker
  • Irvine, CA

Job Description

Stryker seeks an Associate Manager for Quality Assurance in Irvine, California to lead quality operations and ensure compliance across manufacturing. The role involves team leadership, regulatory adherence, and driving continuous improvement initiatives to support product quality and organizational objectives.

Responsibilities

  • Lead and develop Quality Engineering team with coaching and support for cross-functional partners
  • Ensure product, process, and system compliance with Stryker standards and regulatory requirements
  • Oversee investigations, nonconformances, CAPAs, and deviations with timely resolution
  • Monitor quality metrics and drive improvement initiatives to enhance product quality and efficiency
  • Support internal, external, and regulatory audits to maintain site certifications

Requirements

  • Bachelor's degree in Engineering or related Science discipline
  • 6+ years experience in Medical Device, Pharmaceutical, Bio-Medical, Automotive, or regulated manufacturing
  • Expert knowledge of regulatory requirements and audit/inspection management
  • Working knowledge of quality tools: SPC, FMEA, Root Cause Analysis, Poka-Yoke, or Six Sigma
  • FDA-regulated medical device or life sciences environment experience preferred
  • Demonstrated success building and leading high-performing teams
  • Ability to execute strategies and drive organizational change initiatives

Compensation: $118,000 - $196,600 USD Annual

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