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Supplier Quality Leader (Colorado Springs)

Supplier Quality Leader (Colorado Springs)

EPM ScientificColorado Springs, CO, United States
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A leading medical device company is seeking a Supplier Quality Leader to oversee supplier quality operations and ensure compliance across a global supply base. This role will play a key part in supporting product development, manufacturing, and regulatory readiness.

Key Responsibilities :

  • Lead supplier quality activities across multiple product lines and manufacturing sites.
  • Manage supplier audits, assessments, and performance monitoring.
  • Collaborate cross-functionally to support new product introductions and process validations.
  • Drive resolution of supplier-related nonconformances, CAPAs, and quality issues.
  • Support validation efforts including IQ / OQ / PQ, Gage R&R, and other qualification protocols.
  • Ensure compliance with applicable standards (e.g., ISO 13485, FDA QSR).
  • Develop and maintain quality documentation and metrics related to supplier performance.

Qualifications :

  • Minimum of 10 years of experience in quality assurance or supplier quality within a regulated industry, preferably medical devices.
  • Strong background in supplier management, validations, and quality systems.
  • Familiarity with CAPA, NCRs, FMEAs, and root cause analysis.
  • Excellent communication and leadership skills.
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    Supplier Quality Leader • Colorado Springs, CO, United States

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