Quality Assurance and Compliance Specialist
4 days ago
Zentek Ltd., a Canadian nanotechnology company, is seeking a Quality Assurance and Compliance Specialist to lead the establishment and development of their Quality Management System (QMS).
About Zentek
As a pioneering company in next-generation healthcare solutions, Zentek focuses on cutting-edge innovations in nanomaterials. With a mission to create safer, cleaner, and more efficient solutions, Zentek addresses critical areas such as personal protective equipment (PPE), indoor air quality, and diagnostic testing. The company combines proprietary molecular science expertise with strategic partnerships to tackle complex global challenges in health, safety, and environmental protection.
Responsibilities
- Establish and lead a high-performing QA team by recruiting, training, and mentoring members, fostering a collaborative and proactive team culture that meets and exceeds quality objectives.
- Manage and enhance the QMS to ensure compliance with ISO 13485, MDEL, and MDSAP, while implementing process improvements to increase efficiency and regulatory readiness.
- Coordinate and conduct QMS management review meetings to review performance, identify areas for improvement, and implement corrective actions.
- Oversee document control to ensure accuracy, accessibility, and policy adherence, introducing improvements to streamline document management.
- Develop and manage quality control procedures for product release, including inspection, testing, and approvals, working across teams to meet regulatory and customer standards.
Qualifications & Key Attributes
- Bachelor's degree in engineering, science, or a related field; an advanced degree is preferred.
- Minimum of 5 years in quality assurance within the medical device sector, with experience in a leadership or team-building capacity.
- In-depth knowledge of ISO 13485, 21 CFR 820, and Canadian Medical Devices Regulations.
- Familiarity of EU MDR 2017/745, and FDA 510(k) regulatory pathways considered an asset.
Benefits
- Dental care.
- Extended health care.
- Flexible schedule.
- Life insurance.
- Annual office expense reimbursement.
- Cell phone coverage.
Salary
$80,000 - $120,000 per year, depending on qualifications and experience.
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