Project Quality Manager – Medical Devices

Sgh Medical Pharma; Val-Revermont; Sur place; EUR 50 220 - 72 540; Plein temps

Avantages offerts par ce poste

Training on our business areas and产品

Résumé du poste

SGH Medical Pharma Group in France is seeking a Project Quality Manager – Medical Devices for a fixed-term 6-month assignment at our Val-Revermont site. Reporting to the Site Quality Manager, you will safeguard project quality and regulatory documentation across new product files.

Ideal candidates have a degree in quality assurance or biomedical engineering, at least 3 years' experience, and strong ISO 13485 knowledge.

Qualifications

• Higher education in quality assurance, biomedical engineering, or plastics processing.
• At least 3 years of proven experience in a similar role.
• Proficiency in the ISO 13485 standard.
• Industry experience in plastics processing or medical devices.

Responsabilités

• Manage the risk analysis process.
• Facilitate and oversee functional analyses and FMEA at each project phase.
• Participate in the preparation of documentation and design reviews.
• Obtain material compliance certificates.
• Draft quality documents related to new products.
• Verify that all documents required by procedures and standards are included in each file.
• Participate in meetings (internal and external) related to product projects.
• Propose improvements to product quality.
• Monitor projects from a quality and regulatory perspective.
• Draft product presentation sheets.
• Draft inspection procedures and packaging sheets.
• Ensure quality monitoring of new projects.
• Participate in testing new installations.
• Monitor the commissioning and qualification phases of equipment—QC, FAT, SAT, QI, QO, QP.
• Participate in on-site quality audits.
• Participate in supplier audits (as part of new projects).
• Participate in updating or creating QMS documents.
• Guide technical teams in troubleshooting and implementing corrective actions following nonconformities.

Connaissances

Leadership

Analytical skills

Communication skills

Problem solving

Formation

Quality assurance, biomedical engineering, or plastics processing

Description du poste

The SGH Medical Pharma Group is a European leader in medical devices and drug delivery. Building on recent major developments in the field of IVD and as a recipient of funding under the “Industrial Modernization” recovery plan, our group continues to grow and strengthen its structure.

offers a comprehensive range of services, from standard production to custom development, including medical contract manufacturing. In addition to manufacturing at multiple ISO 13485 / 15378 / 14001-certified sites—some of which are ISO 8 cleanrooms—we make our full range of expertise in quality, R&D, industrialization, and marketing available to our customers.

You want to join

An innovative, ambitious company committed to public health, with a project that’s both passionate and meaningful, as part of an expert team full of diverse personalities? We are offering an excellent opportunity for a fixed-term or temporary position of 6 months as a Project Quality Manager – Medical Devices at our Val-Revermont (01) site.

We offer

• A fixed-term or temporary position with a start date between August 24, 2026, and September 1, 2026
  • For a period of 6 months
  • As part of a maternity leave replacement
• Training on our business areas and products

Your missions

Reporting to the Site Quality Manager, you are responsible for ensuring the quality of projects by making sure that all quality and regulatory documentation is properly maintained for each new product file.

• Manage the risk analysis process
• Facilitate and oversee functional analyses and FMEA at each project phase
• Participate in the preparation of documentation and design reviews
• Obtain material compliance certificates
• Draft quality documents related to new products
• Verify that all documents required by procedures and standards are included in each file
• Participate in meetings (internal and external) related to product projects
• Propose improvements to product quality
• Monitor projects from a quality and regulatory perspective
• Draft product presentation sheets
• Participate in drafting inspection procedures and packaging sheets
• Ensure quality monitoring of new projects
• Participate in testing new installations
• Monitor the commissioning and qualification phases of equipment—QC, FAT, SAT, QI, QO, QP
• Participate in on-site quality audits
• Participate in supplier audits (as part of new projects)
• Participate in updating or creating QMS documents
• Guide technical teams in troubleshooting and implementing corrective actions following nonconformities.

Desired candidate profile

• Higher education in quality assurance, biomedical engineering, or plastics processing
• At least 3 years of proven experience in a similar role
• Proficiency in the ISO 13485 standard
• Industry experience (plastics processing or medical devices)

Your strengths

• Leadership and the ability to bring together multidisciplinary teams.
• Strong organizational skills and the ability to manage priorities.
• Excellent analytical and problem-solving skills.
• Strong interpersonal and communication skills.
• Attention to detail, independence, and a proactive approach.

Do you have all these skills? If so, you’re the ideal candidate!

Missing a few? Give it a try and apply. We’ll review your application carefully!

We’re proud to promote diversity and equal opportunity within our teams. We believe that our differences make a difference and that an inclusive work environment will foster our growth as a company, as teams, and as individuals. We’ll therefore consider all applications while fostering an inclusive work culture where everyone feels they belong.