Senior Quality Assurance Leader for Nanomaterials Innovation

1 week ago


Guelph, Ontario, Canada People First HR Services Full time
About the Role

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.
Requirements and Qualifications
  • 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.
About Zentek Ltd.

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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