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People First HR Services
Quality Assurance Manager - Zentek
People First HR Services • Guelph, ON • via LinkedIn
21 hours ago
$80K–$120K a year
Full-time
Apply on LinkedIn
Job descriptionZentek is a Canadian, IP development and commercialization company focused on nanomaterials innovation to advance solutions in health, safety, and environmental sectors. As a leader in molecular science, Zentek combines cutting-edge technology with strategic partnerships to address complex global challenges. The company has a unique, collaborative culture, driven by curiosity and a commitment to excellence. As Zentek continues to advance through New Product Development, they are seeking a Quality Assurance Manager to join their team.
The Quality Assurance Manager will play a pivotal role in establishing and leading the Quality Assurance (QA) function at Zentek, positioning this role as a key contributor to the company’s growth and innovation. With Zentek’s expansion into diverse areas of product development, this position presents a unique opportunity to shape and improve quality processes from the ground up, fostering a culture of continuous improvement. In this role, the QA Manager will oversee and advance Zentek’s Quality Management System (QMS), ensure regulatory compliance, and lead quality initiatives that drive efficiencies and innovation across the organization.
As the successful candidate, you will have experience in quality management within the medical device or health related sectors. In addition, you will be empowered to work closely with cross-functional teams and contribute to an agile and forward-thinking environment that values adaptability, strategic vision, and innovation.
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 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.
• Build 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 the review and approval of technical documentation and engineering change requests as the acting QMS Representative.
• 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.
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.
• 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.
Working conditions:
Flexible work hours
Hybrid working; partial work from home
Role will require Candidate to be on site in Guelph, Ontario as needed for production/site specific quality control activities
Occasional travel required
Applicants must be Canadian residents and legally authorized to work in Canada; the company does not provide visa sponsorship or cover relocation expenses
• Please note that the provided pay range is indicative and may vary based on factors such as experience, qualifications, and skill level. Meeting the minimum job criteria does not guarantee compensation within this range, and final salary determination is at the discretion of the Hiring Manager.
Benefits:
Dental care
Extended health care
Flexible schedule
Life insurance
Annual office expense reimbursement
Cell phone coverage
While we sincerely appreciate every application received, only those candidates selected for an interview will be contacted.
Why Zentek?
Zentek Ltd. is a Canadian nanotechnology company pioneering next-generation healthcare solutions through cutting-edge innovations in nanomaterials. Driven by a mission to create safer, cleaner, and more efficient solutions, Zentek focuses on groundbreaking advancements in prevention, detection, and treatment, addressing critical areas such as personal protective equipment (PPE), indoor air quality, and diagnostic testing. Zentek combines proprietary molecular science expertise with strategic partnerships to tackle complex global challenges in health, safety, and environmental protection. As a fast-growing company, Zentek fosters a dynamic, collaborative culture where curiosity, innovation, and commitment to excellence drive the team to create impactful solutions that protect and enhance people’s lives.
www.zentek.com |
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