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.
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:
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.
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.
The Candidate they seek will likely come with an educational foundation of Engineering, Biomedical Engineering, Chemistry, or related field, and brings OEM experience ideally with Invitro Diagnostics, Medical devices, or Biotechnology field and brings a balance of proficient to expert experience in both RA and QA. This will be a high visibility role so this professional will be the point of contact for regulatory body representatives therefore the ability to prepare and host an audit, manage and fine tune an existing QMS, and lead people and projects in both functions would be preferred. This company is currently catering to global customers so someone who has some exposure to FDA, Health Canada, and or IVDR could bode well.Why is This a Great Opportunity:
We have recently beenengaged by an established, leading edge global leader in point of care testing solutions that have the ability to test for infectious disease, cardiovascular, sepsis, amongst other ailments and provide results in just minutes. This is a Canadian OEM that has a world class R&D team as well as a high technology manufacturing facility and as they continue to get incredible demand for their products (which includes a Covid 19 Antigen Kit) they require aManager RA/QA.