Quality Engineer, Instrumentation
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
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
Knowledge and Qualifications
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
#Nonbench #AB-Hybrid #LI-AB1
STEMCELL Technologies is a privately owned, Vancouver-based biotechnology company that helps power leading-edge life science research around the world. Driven by our love of science and passion for quality, we are a company of Scientists Helping Scientists—standing by our customers to provide the outstanding products, technical support, and training they need to advance their research. 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, accessory products, and services. Through our many regional offices, as well as our distribution centers in Vancouver, Seattle, Grenoble, and Singapore, we deliver our innovative, specialized products to more than 100 countries. With over 1,800 employees globally, most with scientific or engineering degrees, 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.
The annual salary for this job ranges from:
$71,200.00 - $96,400.00STEMCELL determines an individual’s pay within the range based on multiple factors including experience, education, job-related skills, and equity within the team or organization. For jobs that are eligible for sales incentives, the range noted above is inclusive of target incentives; actual incentives are based on individual performance results in accordance with company policy. In addition to base salary, STEMCELL offers a comprehensive total rewards package including health benefits, retirement savings, and more.
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