Manager, QA & RA

Manager, Quality Assurance & Regulatory Affairs

Quality Assurance/Regulatory · VANCOUVER, British Columbia

Who we are looking for:

We are seeking for a motivated, dynamic, solutions-focused, and detail-oriented individual to lead our Quality Assurance & Regulatory Affairs team. This position will be responsible for the continual review and improvement of the quality management systems (QMS) for providing effective and efficient processes.

Key Responsibilities:

Functional Leadership (Quality and Compliance Management)

• Oversees effective day-to-day operations for the quality and compliance functions of the company.
• Oversees the effective development and management of the quality budget(s).
• Responsible for establishing and executing on a Total Quality Management system and driving it through the organization.
• Oversee the internal and external audit program and ensure compliance to all applicable regulations for medical device development and manufacturing operations.
• Provides guidance to internal teams to assure that all operational and development activities conform to business and regulatory requirements.
• Responsible for establishing and maintaining relationships with important professionals and regulatory bodies.
• Attracts, engages, and develops high-performing quality team members.
• Provides a clear and concise vision for the quality and compliance operations team(s) that keeps them focused on results.
• Empowers the team to speak out and is able to manage effectively and removes functional and operational roadblocks by working cross-functionally.
• Develops a cross-company buy in and ensures all team members exhibit a quality mindset.
• Facilitates interdepartmental communication to improve responsiveness and facilitate prompt decision-making.
• Builds team capacity through coaching and thoughtful career planning.

Education, Work Experience, Knowledge, and Skills:

Formal Education

Minimum BSc with at least 8 years experience in the medical device, biopharmaceutical, or biotechnology industries. An equivalent mix of education and experience will be considered.

Work Experience

8 or more years experience in some combination of Regulatory and Quality roles, some portion of which must include a manufacturing environment and medical devices, and at least 4 years with Regulatory responsibilities.

Skills & Knowledge

• Proven ability to create the Quality and Regulatory strategies for an organization and experience lead others to achieve the related goals.
• Extensive knowledge of: FDA (including GMP), EU, and ISO strongly preferred.
• Experience with some medical device manufacturing.
• A proven ability to deliver value in the following areas: supplier quality audits/improvement plans, reliability engineering, fault analysis and troubleshooting, corrective action tracking and quality management training.