DNA Genotek is a rapidly growing Canadian biotech company that has become the recognized world leader in DNA collection products. Our success is based on the strong relationships we've built with our customers and the exceptional talent of our employees. We pride ourselves on offering a fun, positive and high performance environment that supports the continued growth and development of all employees. We hope you are interested in joining our team as we are currently in search of a Quality Engineer.
In this role you will provide quality engineering support to our portfolio of released products, new product introductions and product change activities. You will be a key contributor to the maintenance and improvement of our Quality Management System and you continue to drive quality throughout our business.
Additionally you will:
- 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, and other similar activities.
- Support new product introduction, including risk management, design review, design transfer, quality planning, and other quality related initiatives.
- Be the focal person for the CAPA and SCAR processes.
- Develop and support the Supplier Quality Management process.
- 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 would be an asset.
Experience and Other Requirements:
- 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.
To apply, please visit the About/Careers section of our website to apply to this position at www.dnagenotek.com.