Quality Assurance Director
3 days ago
We are seeking a Quality Assurance Manager to join our team at Zentek Ltd., a Canadian nanotechnology company pioneering next-generation healthcare solutions through cutting-edge innovations in nanomaterials.
As a leader in molecular science, Zentek combines proprietary technology with strategic partnerships to tackle complex global challenges in health, safety, and environmental protection.
The successful candidate will have experience in quality management within the medical device or health-related sectors and be empowered to work closely with cross-functional teams.
Key Responsibilities:
- Establish and lead a high-performing QA team by recruiting, training, and mentoring members.
- Manage and enhance the QMS to ensure compliance with ISO 13485, MDEL, and MDSAP.
- Coordinate and conduct QMS management review meetings to review performance and identify areas for improvement.
- Oversee document control to ensure accuracy, accessibility, and policy adherence.
- Develop and manage quality control procedures for product release.
- Build upon Zentek's supplier quality program by evaluating, auditing, and monitoring suppliers.
Qualifications & Key Attributes:
- Bachelor's degree in engineering, science, or a related field.
- Minimum of 5 years in quality assurance within the medical device sector.
- In-depth knowledge of ISO 13485, 21 CFR 820, and Canadian Medical Devices Regulations.
- Familiarity with EU MDR 2017/745 and FDA 510(k) regulatory pathways is an asset.
Benefits:
- Dental care
- Extended health care
- Flexible schedule
- Life insurance
- Annual office expense reimbursement
- Cell phone coverage
The estimated salary for this position is $95,000 - $120,000 per year, based on industry standards and the location of Guelph, Ontario.
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