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Form of workSTEMCELL is seeking a talented and driven Senior Quality Engineer to lead the launch of innovative new products, ensuring they meet all regulatory and quality standards. In this role, you will be at the forefront of establishing efficient manufacturing processes, guaranteeing consistent production while adhering to design inputs and specifications. Your expertise will be pivotal in creating and implementing procedures that comply with our robust Quality Management System.
As the Senior Quality Engineer, Instrumentation, you will play a key role in supporting the compliance of our dynamic Instrumentation division. At STEMCELL, we are always pushing the boundaries with cutting-edge technologies, and this role will provide you with the opportunity to manage and analyze intricate data, applying critical thinking to drive impactful results for the department and the organization as a whole.
This is a 12 month fixed term position with the opportunity to access our internal jobs boards for full-time extensions.
Job Description
Duties and Responsibilities
- Quality lead for design control process for new products to meet ISO 13485, 21 CFR Part 820 cGMP manufacturing and quality requirements
- Quality review and approval of technical documents, design verification, and validation reports for new products
- Independently lead the risk management activities such as PFMEA and DFMEA
- Create component inspection plans, in-process and final inspection procedures
- Write and update quality and product specific procedures, protocols and test reports
- Bachelor's degree in Engineering, Physical Science, or equivalent field with a minimum of 4 years of experience in a regulated industry
- Detailed knowledge of ISO14971 Risk management requirements, ISO13485 and 21 CFR Part 820 cGMP manufacturing and quality requirements
- Independently led the risk management activities such as PFMEA and DFMEA
- Creation of component inspection plans, in-process and final inspection procedures
- CQA or CQE would be an asset
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 2300 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 base salary for this job ranges from:
$78,640.00 - $118,000.00
STEMCELL 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.
NOTE: STEMCELL'svaccination policy requires that all candidates for this role be fully vaccinated against COVID-19 (including boosters), as currently recommended or required by local health authorities and public health orders, unless an exemption from this policy is approved through our accommodation request process.
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