Quality Manager | Manufacturing | Montreal
5155 Avenue Decelles Montreal, QC CA
- Oversees maintenance of the QMS (Quality Management System) and ensures that documentation (Quality Manual, SOPs, DHFs) is compliant with Health Canada and FDA regulations regarding medical devices and software.
- Conduct and oversee internal audit program to establish and implement corrective actions and modifications of documentation procedures
- Coordinate external audit by ISO 13485 registrar
- Train and prepare software and engineering team for external audits
- Oversee all quality compliance activities including Quality alerts, Risk Management, Quality Agreements, Verification and Validation.
- Ensures all regulatory files are secured and maintained in approved regulatory formats (database) for updating, retrieval, and purposes of regulatory inspections
- Support for investigational testing applications and medical device license applications in North America and the EU.
- Review and implement all changes regarding US FDA, European, and Canadian quality standards required by regulatory updates
- Coordinate responses to any regulatory changes required
- Work with outside suppliers and contract manufacturing partners to ensure that they meet with required quality standards.
- Bachelor's Degree in Science/Engineering. Masters or PhD in science/engineering is preferred.
- Knowledge of QA systems and regulatory frameworks pertaining to medical devices (QSR, MDD, and ISO 13485:2003 requirements),
- Certificate in QA or RA preferred
- Experience in medical device company or pharmaceutical company is required, preferably at least 5 years of QA/RA experience.
- Project management certification is a plus.
Years of Experience: 5+ Years quality experience
Degree: BS (PhD pref.)
This job description is not intended to be all-inclusive and may have been abbreviated or maximized for online or mobile viewing. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Legacy MedSearch was named to the 2019 Forbes list of Best Recruiting Firms in America
Meet Your Recruiter
Arshad is a seasoned recruiter in the healthcare space with over 15 years of experience in promoting career growth for healthcare professionals. He has played a critical role in the launch of several startup companies. He is known for versatility and leadership; expert in overseeing high-level priorities and a broad range of responsibilities.