Senior Quality Engineer

STEMCELL Technologies Canadas largest biotech company is looking for a Senior Quality Engineer to join our team out of our Cambridge Waterbeach site!

As the Senior Quality Engineer you will support the development and manufacture of innovative instrumentation and single-use consumables for GMP cell and gene therapy manufacturing as well as research use only (RUO) applications. Working closely with Engineering Manufacturing and the broader Quality team you will provide quality expertise throughout the product lifecycle ensuring products meet applicable regulatory and quality requirements.

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 ISOCFR 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

• Bachelors degree in Mechanical Electrical Software or Biomedical Engineering with 610 years of relevant experience or a Masters 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 Scientistsstanding 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 1800 employees globally most with scientific or engineering degrees STEMCELL is proud to be the largest biotechnology employer inCanada.

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 Canadas 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:

46100.00 - 69100.00

STEMCELL determines an individuals 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 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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