Job Description

Job ID R0005918 Date posted 07/28/2023

Summary

We are 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. 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.



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\xc3\x82

Knowledge and Qualifications

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

#NonBench #LI-Hybrid

STEMCELL Technologies 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.\xc3\x82 Driven by our love of science and our passion for quality, we see ourselves simply as \xc3\xa2\xc2\x80\xc2\x9cScientists Helping Scientists\xc3\xa2\xc2\x80\xc2\x9d \xc3\xa2\xc2\x80\xc2\x93 standing by our customers to provide outstanding products, technical support and training.\xc3\x82 We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree.\xc3\x82 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\xc3\xa2\xc2\x80\xc2\x99s Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.\xc3\x82

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\xc3\xa2\xc2\x80\xc2\x99s\xc3\x82 vaccination 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.

To apply, please select the \xc3\xa2\xc2\x80\xc2\x9cApply\xc3\xa2\xc2\x80\xc2\x9d button below. You will then be directed to a login screen asking you to set up an account, which is required to apply.\xc3\xa2\xc2\x80\xc2\x8b\xc3\xa2\xc2\x80\xc2\x8b

Stemcell Technologies