Project Quality Manager – Medical Devices

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
• 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.

• With a college degree in quality assurance, biomedical engineering, or plastics technology, you have at least one year of professional experience in project-based quality assurance, gained through a job, internship, or work-study program.
• Knowledge of the ISO 13485 standard
• Good working knowledge of English

• 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.

A great opportunity for a recent graduate!

Don’t meet all the requirements? Apply anyway! Your motivation and ability to quickly develop new skills will count just as much.

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.

All applications will be considered regardless of origin, background, religion, gender, sexual orientation, gender identity, disability, etc.