Senior Quality Assurance Leader for Nanomaterials Innovation
1 week ago
Zentek is a pioneering Canadian nanotechnology company, dedicated to developing next-generation healthcare solutions through cutting-edge innovations in nanomaterials. As a leader in molecular science, Zentek combines proprietary expertise with strategic partnerships to tackle complex global challenges in health, safety, and environmental protection.
Key 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 Quality Management System (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.
- Broaden upon Zentek's supplier quality program by evaluating, auditing, and monitoring suppliers to drive continuous improvement initiatives in supplier quality and reliability.
- Monitor the effectiveness of product quality testing, including reviewing and approving technical documentation and engineering change requests as the acting QMS Representative.
- 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 with EU MDR 2017/745 and FDA 510(k) regulatory pathways considered an asset.
- Proven skills to effectively communicate strategies and articulate risks associated with decisions, fostering collaboration and informed decision-making across teams.
- A positive attitude and commitment to continuous personal and professional growth through ongoing learning and development.
- Strong analytical, problem-solving, and communication skills, with the ability to adapt to change and excel in a dynamic, growth-oriented environment.
Zentek Ltd. is a fast-growing company focused on groundbreaking advancements in prevention, detection, and treatment, addressing critical areas such as personal protective equipment (PPE), indoor air quality, and diagnostic testing.
We foster a dynamic, collaborative culture where curiosity, innovation, and commitment to excellence drive our team to create impactful solutions that protect and enhance people's lives.
What We Offer- Estimated salary: $90,000 - $110,000 per year.
- Dental care.
- Extended health care.
- Flexible schedule.
- Life insurance.
- Annual office expense reimbursement.
- Cell phone coverage.
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