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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.
Job Responsibility
Ensure 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
Review and/or approve design input data
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
Requirements
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)
Fluent in English
Nice to have
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