Qc Inspecteur

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
- A minimum of a technician level is required, preferable in Engineering or a related technical discipline.
- Minimum 2 years of professional work experience within a quality assurance or compliance audit environment is required. Experience working in a Medical Device manufacturing environment is preferred.
- Good level in French and English
- Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820
- Good communication, organizational, negotiation and interpersonal skills
- Good analytical problem solving skills.
- Use of Agile, Oracle, EtQ, Minitab
- Use of Microsoft office tools
- Good knowledge of statistical techniques
- Expertise in measurement technics
- Ensures that adequate Quality support is provided to productions and to open projects / initiatives
- Ensures that Nonconformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
- Ensures that quality activities for validation of new programs are performed and documented according to procedures and within the defined timeline
- Write protocols and reports for validation documentation (such as measurement programs validation)
- Participate to risk analysis activities (PFMEA)
- Ensures that GMP rules are known, understood and respected on the site
- Ensure technical support to QC operators
- Train QC operators to measurement technics
- Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a compliant manner
- Participates and supports internal and third party audits / inspections
- Manages or participates to quality projects
- Provides support to complaint investigation if required
- Participate to procedure elaboration or update
- Ensure resources are correctly filled in the project database