Regular Full-Time / Part Time Full-Time
The Quality Engineer is responsible for providing quality engineering support to our portfolio of released products, new product introduction and product change activities, and contributing to maintenance and improvement of our Quality Management System.
RESPONSIBILITIES / DELIVERABLES:
- Support the change management process for released products.
- Support process controls and risk management internally and at sub-contractors.
- Lead or support incoming inspection, corrective and preventive actions, continuous improvement projects, internal and supplier audits, quality metrics, non-conformance and complaint investigations, etc.
- Support new product introduction, including risk management, design review, design transfer, quality planning, etc.
- Be the focal person for the CAPA and SCAR processes.
- Develop and support the Supplier Quality Management process.
- Other duties deemed appropriate for a Quality Engineer.
- Degree in a science or engineering discipline, or an equivalent combination of relevant job experience, training and knowledge.
- Recognized Quality Management System training or certifications such as Certified Quality Engineer, Certified Supplier Quality Engineer,
- ISO 9001 / 13485 auditor certification an asset.
- Minimum 5 years experience in an engineering role preferably in the medical device or similarly regulated industry.
- Experience building productive, collaborative relationships with key external suppliers
- Demonstrated resourcefulness and ability to work with a diverse set of tasks and responsibilities.
- Strong time management and organizational skills
- Excellent written and oral communication skills.
- Experience with quality tools such as FMEA, Measurement System Analysis, Process Capability, Equipment and Process Validations, Design of Experiments, Root Cause Analysis, etc.
- Experience with statistical tools including SPC.
- Experience with supplier audits and internal audits.
- Familiarity with ISO 13485:2003 and medical device GMP regulations.
- Proficiency in MS Office Applications.
- Willingness to travel to supplier sites
At DNA Genotek, we are committed to building and preserving an accessible, welcoming, supportive, fair, and inclusive environment.Accommodations are available to support prospective employees during the recruitment and hiring process. Should you require any accommodations, please advise us in advance so that we can work with you to find a suitable accommodation.