Senior Quality Assurance Manager

1 week ago

Guelph, Ontario, Canada People First HR Services Full time
Quality Assurance Manager Job Description

Zentek Ltd. is a leading Canadian nanotechnology company dedicated to pioneering cutting-edge innovations in healthcare solutions through the application of advanced nanomaterials.

As a fast-growing company, Zentek fosters a dynamic and collaborative culture where curiosity, innovation, and commitment to excellence drive the team to create impactful solutions that protect and enhance people's lives.

About the Role

The Quality Assurance Manager will play a pivotal role in establishing and leading the Quality Assurance (QA) function at Zentek, contributing significantly to the company's growth and innovation.

This position presents a unique opportunity to shape and improve quality processes from the ground up, fostering a culture of continuous improvement.

The QA Manager will oversee and advance Zentek's Quality Management System (QMS), ensuring regulatory compliance and leading quality initiatives that drive efficiencies and innovation across the organization.

Key Responsibilities
  • Team Leadership: 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.
  • Quality Management System (QMS): Manage and enhance the QMS to ensure compliance with ISO 13485, MDEL, and MDSAP, while implementing process improvements to increase efficiency and regulatory readiness.
  • Document Control: Oversee document control to ensure accuracy, accessibility, and policy adherence, introducing improvements to streamline document management.
  • Product Release: Develop and manage quality control procedures for product release, including inspection, testing, and approvals, working across teams to meet regulatory and customer standards.
  • Supplier Quality: Build upon Zentek's supplier quality program by evaluating, auditing, and monitoring suppliers to drive continuous improvement initiatives in supplier quality and reliability.
  • Internal Audits:
  • Lead internal audits of the QMS, apply ISO 14971 principles for risk management, and drive continuous improvement initiatives to enhance overall quality processes and systems.
Requirements and Qualifications

To be successful in this role, you will need:

  • 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.
  • Proven skills to effectively communicate strategies and articulate risks associated with their decisions, fostering collaboration and informed decision-making across teams.
  • A positive attitude and a 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.
  • Demonstrated ability to build, inspire, and develop high-performing teams, with a collaborative approach to decision-making.
  • Proven track record in applying a flexible, strategic, and innovative perspective to quality management.
  • Lead Auditor in ISO 13485, ASQ, SQA, or RAPS certification is desirable.
What We Offer

Zentek offers a competitive salary range of $100,000 - $140,000 per annum, commensurate with experience, along with a comprehensive benefits package, including dental care, extended health care, flexible schedule, life insurance, annual office expense reimbursement, and cell phone coverage.

Located in Guelph, Ontario, this role requires occasional travel and the ability to work on-site as needed for production/site-specific quality control activities.

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