Quality Assurance Engineer

hace 7 días


Juárez, Chihuahua, México Integer Holdings Corporation A tiempo completo
{"title": "Quality Assurance Engineer", "content": "Job Summary

Integer Holdings Corporation is seeking a highly skilled Quality Assurance Engineer to support the administration of our Quality Management System. As a key member of our team, you will be responsible for ensuring compliance with established standards, client and/or medical devices industry requirements, government regulations, and other applicable standards.

Key Responsibilities
  • Administer the Quality Management System for compliance with ISO 13485, 21 CFR Part 820, COFPERIS, Japan and Brazil, and GMP regulatory requirements.
  • Coordinate the Internal Audit Process and participate in customer and notify body audits.
  • Ensure all associated documentation and procedures are in compliance, including trending and reporting of these activities.
  • Act as Lead Auditor or team member and coordinate audits activities with team members.
  • Review audit results with coordinator and other assessment team members to verify and document evidence of compliance.
  • Provide management with updates on status of work, initiatives, and projects as required.
Requirements
  • Minimum 3 to 5 years' experience in GMP Audits in the medical device industry.
  • Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485.
  • Root Cause Analysis and Investigations experience.
  • Strong communication skills (verbal, written, and presentation).
  • Good interpersonal and negotiation skills.
About Integer Holdings Corporation

We are a company that values our employees and strives to create a culture that unifies and positions us for long-term success. We are committed to our customers' success and create better solutions through innovation and collaboration.

", "lang_code": "en-US"}

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