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About Zentek: 

Zentek Ltd. (TSX-V:ZEN, , Nasdaq: ZTEK),  is an IP development and commercialization company that uses expertise in nanomaterials and strategic partnerships to break through the barriers of molecular science and uncover new possibilities in health, safety, and the environment. We believe our proven, next-generation, patented nanotechnologies will help solve the world’s most complex challenges. We are dynamic, fast-paced, and building a unique culture from the molecule up! 

Job Description: 

We are seeking a dedicated and proactive Quality Assurance Manager to join our dynamic team. This role offers the unique opportunity to build and lead the Quality Assurance (QA) team from the ground up in a fast-paced environment. Our team is currently navigating various certifications and regulatory requirements in the medical device industry, including ISO 13485:2016, MDEL with Health Canada, MDSAP, EU-MDR, and FDA 510K, and this role would support these activities.

The ideal candidate will possess a positive attitude, a commitment to growth, and the ability to integrate seamlessly into our team dynamics. Additionally, the candidate should be open to continuous learning as our company expands into diverse product development areas beyond medical devices.

Responsibilities: 

·       Build and Lead QA Team: Establish and cultivate a high-performing QA team by recruiting, training, and mentoring team members. Provide leadership and guidance to ensure the team's success in meeting quality objectives.

·       QMS Management: Oversee the Quality Management System (QMS) to ensure compliance with regulatory requirements and industry standards. Coordinate and conduct QMS management meetings to review performance, identify areas for improvement, and implement corrective actions. This will additionally include reviewing and authoring a variety of Quality Management Documentation such as Standard Operating Procedures (SOPs).

·       Document Control Oversight: Manage document control processes to maintain accuracy, integrity, and accessibility of quality documentation. Maintain recently improved document control procedures and ensure adherence to document control policies throughout the organization.

·       Quality Control Release: Implement and manage quality control procedures for product release, including inspection, testing, and approval processes. Collaborate with cross-functional teams to ensure product quality meets regulatory and customer requirements.

·       Supplier Quality: Build upon existing supplier quality portfolio to evaluate and monitor suppliers' performance. Conduct supplier audits, assess supplier capabilities, and drive continuous improvement initiatives to enhance supplier quality and reliability.

·       Regulatory Compliance: Ensuring the QMS maintains regulatory compliance while proving QA expertise to our existing regulatory team including documentation support where required for items such as ISO 13485, MDEL, MDSAP, EU-MDR, and FDA 510K.

·       Internal Audits: Lead and execute internal audits of the Quality Management System. Prepare audit reports, document findings, and follow up on nonconformances.

·       Product Quality: Monitor the effectiveness of product quality testing including documentation of test results, review and approval of technical documentation, and the review/ approval of engineering change requests.

·       Risk Analysis: Familiarity and ability to apply ISO 14971 as it relates to the company’s overall execution of risk management. Participations in product risk assessment and analysis sessions, as well as high level risk as it applies to the management of the QMS.

·       Continuous Improvement: Drive continuous improvement initiatives to enhance the effectiveness and efficiency of quality processes and systems. Foster a culture of quality and innovation by encouraging team members to identify and implement opportunities for improvement.

Experience & Key Attributes: 

• Bachelor's degree in engineering, science, or related field; advanced degree preferred.
• Minimum of 5 years of experience in quality assurance in the medical device industry.
• Working knowledge of a Quality Management System, and requirements of ISO 13485, Canadian Medical Devices Regulations SOR/98-282, 21 CFR 820 Quality System Regulations, EU Medical Device Regulations 2017/745 and FDA medical device regulatory paths, particularly 510(k) requirements.
• Lead ISO 13485 Auditor, ASQ, SQA, or RAPS certification desirable.
• Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
• Familiarity with ISO 14971:2019 for medical device risk management activities and utilising a risk-based approach to QMS processes
• Proven leadership experience with the ability to build, develop, and lead high-performing teams.
• Excellent communication skills with the ability to effectively collaborate with cross-functional teams and external stakeholders.
• Detail-oriented with strong analytical and problem-solving skills.
• Demonstrated ability to drive continuous improvement initiatives and implement best practices.
• Positive attitude, adaptable to change, and committed to personal and professional growth.

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

Job Types: Full-time, Permanent 

Salary: $80,000 - $120,000 CAD*

*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. 

Requirements

• Work Permit