Project Quality Officer (M/F) – Medical Devices

SGH Medical Pharma company; Enclos Rousset; Hybrid; EUR 33,000 - 47,000; Full time

Benefits offered by this job

Remote work after induction (2 days)

Training in business areas and product

Job summary

SGH Medical Pharma Group invites applications for a Project Quality Officer (M/F) for Medical Devices, based at the Rovipharm site in Val-Revermont (01). The role drives quality and regulatory documentation for new product dossiers and supports audits, risk analyses, and design reviews.

The successful candidate will have 3+ years in a similar role, ISO 13485 proficiency, and English language skills, with two remote work days after induction as part of a hybrid arrangement.

Qualifications

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

Responsibilities

• Manage the risk analysis process.
• Lead and oversee FMEA at each stage of the project.
• Draft quality documents relating to new products.
• Attend meetings relating to product projects.
• Monitor projects from a quality and regulatory perspective.
• Assist in drafting inspection procedures and packaging specifications.
• Monitor the quality of new projects.
• Guide technical teams in problem-solving and corrective actions following non-conformities.

Skills

Quality assurance

Regulatory knowledge

Leadership

English proficiency

Education

Higher education in QA/biomedical engineering/plastics

Job description

Project Quality Officer (M/F) – Medical Devices

The SGH Medical Pharma Group (Stiplastics, Rovipharm, SGH Tunisia) is a European leader in medical devices and drug delivery. Building on recent major developments in the field of in vitro diagnostics, and as a recipient of funding under the ‘industrial modernisation’ recovery plan, our group continues to grow and consolidate its structure.

The SGH Medical Pharma Group now offers a comprehensive range of services, from standard production to bespoke development, including medical contract manufacturing. In addition to manufacturing across multiple sites certified to ISO 13485, 15378 and 14001 – some of which are ISO 8 cleanrooms – we make our full range of expertise in quality, R&D, industrialisation and marketing available to our clients.

Would you like to join

• An innovative, ambitious group committed to public health
• A project driven by passion and purpose
• A team of experts with a wealth of personalities

We are offering a 7-month fixed-term or temporary role based at our Rovipharm site in Val-Revermont (01)

Take advantage of

Two days of remote working are possible after the induction period.

Training in our business areas and products

Your role

Reporting to the Site Quality Manager, you will be responsible for ensuring the quality of projects by guaranteeing that all quality and regulatory documentation is in order for each new product dossier.

• Manage the risk analysis process
• Lead and oversee functional analyses and FMEA at each stage of the project
• Review and/or approve design input data
• Contribute to the drafting of dossiers and design reviews
• Obtain material compliance certificates
• Draft quality documents relating to new products
• Check that all documents required by procedures and standards are included in each dossier
• Attend meetings (internal and external) relating to product projects
• Suggest improvements to product quality
• Monitor projects from a quality and regulatory perspective
• Draft product presentation sheets
• Assist in drafting inspection procedures and packaging specifications
• Monitor the quality of new projects
• Assist in carrying out tests on new installations
• Monitor the commissioning and qualification phases of equipment – QC, FAT, SAT, QI, QO, QP
• Take part in on-site quality audits
• Take part in supplier audits (as part of new projects)
• Help update or create QMS documents
• Guide technical teams in problem‑solving and the implementation of corrective actions following non‑conformities.

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

Your strengths:

• Leadership and the ability to bring multidisciplinary teams together.
• Organisational skills and the ability to manage priorities.
• Excellent analytical and problem‑solving skills.
• Good interpersonal skills and the ability to communicate effectively.
• Rigorous approach, ability to work independently and a proactive attitude.

We’re proud to promote diversity and equal opportunities within our teams. We firmly believe that our differences make a difference and that an inclusive working environment will drive our growth as a company, as teams and as individuals. We’ll therefore consider all applications*, fostering an inclusive working culture where everyone can feel they belong.
All applications will be considered regardless of origin, background, religion, gender, sexual orientation, gender identity, disability…