Job Description Summary
Our Quality Engineering team is expanding and we are looking for new people to join Canada's largest biotechnology company!
If you're passionate about supporting, developing, and implementing strategies to maintain compliance, this role as a Quality Engineer in our Instrumentation team is for you! In this role, you will have the opportunity to exercise independent judgment in evaluating complex problems and applying current methodologies and practices to resolve identified issues and fill potential gaps. STEMCELL Technologies is a dynamic workplace that pursues cutting edge technologies and practices which translates to you managing complex sources of data that require in-depth critical thinking and reviewing the impact to the department and organization.Job Description Duties and Responsibilities
Knowledge and Qualifications
- Support the Quality Management System (QMS) as it pertains to our instruments, ensuring compliance with applicable medical device regulations and standards
- Leads the development of metrics that report on the effectiveness of processes, status of improvement opportunities and progress against performance objectives to drive Continuous Improvement
- Maintain document control, prepare SOPs, Work Instructions and other Quality Records, and review of design changes that support the change control process
- Lead root cause investigations and activities for non-conformance and corrective and preventive action. Communicates with suppliers, contract manufacturers and internal departments for any issues and non-conformance
- Participate in the internal audits, supplier audits, customer audits and/or ISO and other compliance audits by regulatory bodies
- Bachelor's Degree in Engineering, with a minimum 3 years of industry experience
- Excellent technical report writing and strong ability to understand and analyze technical documents
- Experience with Quality Management System requirements, including non-conformance reports (NCRs) and Supplier Corrective Action Requests (SCARs)
- The ability and the drive to work in a fast-paced environment and have a strong sense of project ownership are essential
- Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certifications would be an asset
This role requires being fully vaccinated against COVID-19 as per STEMCELL's vaccination policy, the current recommendations by local health authorities and as required by public health orders in place from time to time, including any COVID-19 boosters as recommended by local health authorities and as required by public health orders in place from time to time.
STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as "Scientists Helping Scientists" - standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada.
This is an opportunity to work with highly motivated colleagues in a science-oriented, creative, and dynamic environment. We offer a competitive salary, excellent benefits, and meaningful career development opportunities.
STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada's Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.
As an equal opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. We know that scientific progress and innovation occur when diverse, creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.
NOTE: STEMCELL's vaccination policy requires that all candidates for this role be fully vaccinated against COVID-19 (including with boosters) against COVID-19, as currently recommended or required by local health authorities and public health orders.
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