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Chef de projet dispositifs médicaux

PLASTIC ELECTROMECHANIC COMPANY PEC · Bir Mcherga

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ISO 13485 5S Lean Manufacturing Kaizen

Job description

About the role

We are looking for a Project Manager to lead the production of medical devices at our facility in Bir Mcherga. The role ensures that manufacturing and assembly processes meet strict quality and regulatory standards while supporting continuous improvement initiatives.

Key responsibilities

  • Oversee the fabrication and assembly of medical devices according to work instructions.
  • Monitor production parameters, perform in‑process and final quality checks, and report any anomalies.
  • Ensure compliance with ISO 13485, Good Manufacturing Practices (BPF) and other applicable standards.
  • Maintain traceability records, handle non‑conformities and drive corrective actions.
  • Conduct first‑level equipment verifications and signal technical failures.
  • Participate in series changes, first‑level set‑ups and continuous‑improvement projects such as 5S, Lean Manufacturing and Kaizen.
  • Uphold clean‑room hygiene, safety procedures and keep the workstation organized.

Required profile

  • Bachelor’s degree (Bac+3) in Biomedical Engineering, Industrial Engineering or a related field.
  • Minimum 2 years of experience in the medical‑device, pharmaceutical or regulated industrial sector.
  • Familiarity with ISO 13485 and BPF requirements.
  • Ability to read and interpret technical procedures and work instructions.

Required skills

  • Knowledge of ISO 13485 standards.
  • Good Manufacturing Practices (BPF) expertise.
  • Traceability and quality‑control procedures.
  • Use of measurement and control tools.
  • Experience with 5S, Lean Manufacturing and Kaizen methodologies.

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Published 2 weeks ago

Expires 1 month from now

27 views · 0 interested

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PLASTIC ELECTROMECHANIC COMPANY PEC

Bir Mcherga