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Duties and Responsibilities
Lead Design Control and risk management activities, including Hazard Analysis and Design and Process FMEA, to identify and control risks and ensure compliance with ISO 13485, 21 CFR Part 820, cGMP, ISO 14971, IEC 60601-1, IEC 61010-1, RoHS and WEEE and other applicable requirements
Evaluate and approve technical documentation, Design input documents, verification and validation reports, vendor qualification and design transfer activities and overall independent quality support for the project
Develop and implement risk-based inspection plans and in-process and final inspection procedures, including appropriate sampling strategies for instrumentation components
Performs quality inspection/processing of incoming raw materials and final inspection testing
Builds and maintains quality metrics and supports all QMS activities such as document management, non conformance investigations (NCRs/SCARs), CCRs, CAPAs, internal and external audits and factory inspections
Knowledge and Qualifications
Bachelor’s degree in Mechanical, Electrical, Software, or Biomedical Engineering with 6–10 years of relevant experience, or a Master’s degree with 4+ years of experience; an advanced degree is preferred
Experience in an instrumentation or manufacturing environment is preferred
Strong systems knowledge, including experience with Enterprise Resource Planning, Product Life Cycle Management, and Requirements Management Systems, is considered an asset
Strong knowledge across mechanical, electrical, and software engineering disciplines, with extensive understanding of applicable regulatory and quality standards
Demonstrated ability to review complex designs, develop risk management documentation, and establish processes that support manufacturing in alignment with design specifications
#LI-KK1 #LI-Onsite #Bench
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:
£46,100.00 - £69,100.00STEMCELL 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 that may include health benefits, retirement savings, and more (depending on region).
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