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Senior Quality Incoming/Process Supervisor

stryker · Grecia

New
Senior 🇬🇧 English
ISO 13485 MDSAP Quality Management System regulations corrective and preventive actions quality audits

Job description

About the role

The Senior Quality Incoming/Process Supervisor leads and supervises Quality Control teams responsible for incoming, in‑process, and finished product inspections in a regulated medical‑device environment. This role ensures product release timelines, regulatory compliance, and continuous improvement of quality processes.

Key responsibilities

  • Lead and supervise QC teams across shifts, overseeing inspections, document review, and validation testing.
  • Review and approve quality records, inspection results, and batch documentation according to established procedures.
  • Coordinate product holds, disposition activities, non‑conformance investigations, and corrective‑action implementation.
  • Monitor quality metrics and trends to identify risks and drive data‑based process improvements.
  • Partner with Engineering, Manufacturing, and other functions to communicate quality requirements and support product and process enhancements.
  • Support internal and external audits and maintain compliance with quality system and regulatory requirements.

Required profile

  • Bachelor’s degree in Engineering or a related technical field.
  • Minimum 5 years of experience in Quality Engineering, Quality Control, or Quality Assurance within a regulated manufacturing environment.
  • At least 2 years of experience leading or supervising quality personnel.
  • Advanced proficiency in English and Spanish, both written and verbal.

Required skills

  • Strong knowledge of Quality Management System regulations, ISO 13485, and the Medical Device Single Audit Program (MDSAP).
  • Experience with corrective and preventive actions, non‑conformance investigations, and root‑cause analysis methodologies.
  • Experience supporting internal and external quality audits.

Questions fréquentes

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Source : ats:workday

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Published 1 hour ago

Expires 1 month from now

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stryker

Grecia