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|Title:||Senior Quality Director Medical Device|
|Job Location:||Gananoque, Ontario - Canada|
|Salary:||contact recruiter for details|
|Other Compensation:||relocation, benefits|
|Employer Will Recruit From:||
has to be legally allowed to work in Ontario
Senior Quality Director: Medical Device / Bioengineering / Cytotherapy
Join a fast growing company in Eastern Ontario, on the cutting edge of bioengineering, providing living solutions for a variety of clinical treatments. Your strong leadership skills are required to guide this company, part of a large global organization, in terms of quality, compliance, audits, safety, ensuring excellent product development.
ROLE AND RESPONSIBILITIES:
- Key member of site leadership team.
- QC / QA responsiblity, meeting company objectives while in compliance with GMP/ISO 9001 and 13485, building team member consensus.
- In charge of customer on-site audits, setting up supplier quality programs, supporting R&D, and planning strategy for global process development and controls.
- Interacting with global gene therapyand cellular therapy, while partnering with personalized medicine units.
- Company wide safety education and compliance.
- BS / B.Sc. minimum in life sciences / related.
- Proven experience in key bio leadership role(s), at senior upper management level.
- 10 years (post graduation) as key Quality Leader in manufacturing of either medical device (FDA Class 2 (II) or above), cell based biologics, medical equipment, or laboratory analytical or diagnostic instruments.
- Strong people management, departmental management skills, able to see the big picture.
- Proven experience guiding a multi-unit company within a complicated business structure.
- Background in QA / QC product development within matrix organization.
- Interacting with external and internal stakeholders, clients.
- Great at gaining consensus.
- Knowledgeable re USFDA 21CFR820 - such as documentation, facilities design controls, supply chain, audits, training, clean room ISO, failure modes and effects analysis (FMEA).
- Willing to live in / relocate to Kingston, ON area.
- Must be legally allowed to work in Canada at this time.
University - Bachelor's Degree/3-4 Year Degree