BOMImed Inc. is seeking a Quality Assurance & Regulatory Lead to join our team. The ideal candidate will be responsible for the Quality Management System (QMS) and ensuring compliance with applicable regulatory requirements, including device and establishment licensing. This role involves educating the BOMImed team on quality practices and leading the quality team to meet organizational goals.
Duties & Responsibilities:
- Develop and deliver quality training for new employees to ensure a strong understanding of the Quality Management System (QMS).
- Implement and manage key quality processes, including non-conformance handling, complain management, internal audits, document control, Corrective and Preventative Actions (CAPA), and inspections.
- Collaborate with management to develop and maintain documentation necessary to meet quality objectives and regulatory requirements.
- Schedule, chair, and document Material Review Board (MRB) and Quality Management meetings, including the distribution of meeting minutes.
- Reporting of Quality and Regulatory metrics, status, and issues in the Operations Monthly Report.
- Ensure compliance with ISO standards and regulatory requirements by maintaining current knowledge and executing proper implementation.
- Manage device and establishment registrations with Health Canada and the FDA.
- Support vendor evaluations and ongoing maintenance to ensure quality standards are met.
- Work with other departments to provide quality insight.
- Perform other related duties as assigned.
- Perform procedures as outlined in the BOMImed Quality Management System.
Skills & Qualifications:
- Exceptional written and verbal communication skills, with the ability to create clear and accurate documentation.
- Strong analytical, critical thinking, and problem-solving abilities.
- Proven ability to manage multiple tasks efficiently while maintaining a high level of accuracy and meeting deadlines.
- In-depth knowledge and experience with ISO 13485 standards and regulatory requirements.
- Excellent leadership and project management skills, with the ability to guide and develop team members effectively.
- Assertive, independent, and highly organized, with strong time management abilities to handle the position’s demands.
- Skilled in prioritizing tasks and managing job requests based on urgency and importance.
- Detail-oriented with a solid foundation in record-keeping practices and maintaining organized documentation.
- Proficient in Microsoft Office applications, including Word, Excel, and Outlook, as well as internal computer systems.
Education & Experience:
- 5 years of Quality Assurance experience
- Quality Assurance and/or Regulatory Affairs education an asset
- Knowledge and experience with ISO 13485 or other relevant quality standards i.e. 9001
BOMImed offers a competitive salary, comprehensive benefit package and a positive work environment. If you believe this is an opportunity that is well matched to your skill set and capabilities, please apply.
BOMImed is an equal opportunity employer and welcomes applications from all qualified candidates. We thank all applicants for their interest, but only those selected for an interview will be contacted.
Job Types: Full-time, Permanent
Benefits:
- Casual dress
- Company events
- Company pension
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site gym
- On-site parking
- Paid time off
- Vision care
Education:
Experience:
- Quality assurance: 5 years (preferred)
Work Location: In person
