Job Description

Summary

We are looking for a Senior Manager for our Quality Engineering team who will be responsible for driving the Risk Management Process and Quality Management System (QMS) for our instrumentation products. You are a strategic person who can consider the market from a global perspective, and effectively implement processes that meet and exceed quality standards. You are someone who is instrumental to building effective teams, continuously improving systems, and translating complex sources of data into digestible communications to the department and organization. You are driven to provide highly reliable, consistent, and trusted products to our customers and clients, and have been instrumental to conquering ambiguous situations. If you are looking for an opportunity to pursue cutting edge technologies while utilizing your regulatory and product development experience, we encourage you to apply today!

Duties and Responsibilities

• Define and implement systems and processes for new product development to meet the 21 CFR part 820 (including design control requirements), ISO 13485, ISO14971, and any other applicable standards
• Provides design quality leadership for product development and design changes
• Guide the project team on design and the applicable regulatory standards for electromechanical products
• Lead quality assurance and quality improvement initiatives including supplier qualification, design assurance programs and design transfers
• Develop and improve on the risk management process ensure the process meets ISO14971 requirements

Knowledge and Qualifications

• Bachelor\'s degree in a life science-related field with a minimum of 10 years of industry experience in quality assurance, process improvement in the biotech regulated industry or equivalent
• Minimum of 5 years of leading and managing teams
• Extensive knowledge of Quality System regulatory requirements (CE mark, IEC 61010, IEC 60601, IEC 61326)
• Proven ability in coordinating efforts to support, mentor and audit Quality Management System requirements
• Ability to apply scientific and technical knowledge, critical analysis and decision making skills to identify and resolve issues

#NonBench #LI-Hybrid 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 \xe2\x80\x9cScientists Helping Scientists\xe2\x80\x9d \xe2\x80\x93 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\xe2\x80\x99s 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\xe2\x80\x99s 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 \xe2\x80\x9cApply\xe2\x80\x9d button below. You will then be directed to a login screen asking you to set up an account, which is required to apply.