Quality Engineer, Quality Assurance, Instrumentation
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 “Scientists Helping Scientists” – 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.
Job Description Summary
The Quality Engineer, Quality Assurance, Instrumentation role at STEMCELL supports the development and implementation of strategies to create and maintain the compliance of the Instrumentation division as a whole. It gives the opportunity to exercise independent judgment in evaluating complex problems and applying current methodologies and practices to resolve identified issues and fill identified gaps. STEMCELL is a dynamic workplace that pursues cutting edge technologies and practices which translates to this role managing complex sources of data that require in-depth critical thinking and reviewing the impact to the department and organization.
Duties and Responsibilities
Ensures appropriate procedures, processes and policies are established and implemented for quality assurance activities to assure compliance with applicable medical device regulations and standards.
Supports implementing quality by design and design control for medical devices.
Educates trains, advises and coaches employees to ensure adherence to all applicable quality standards for assigned areas.
Maintains and improves product quality by completing product, company, system, compliance, and surveillance internal and external audits and leads third party audits as required.
Supports day-to-day QA investigations on product complaints, corrective and preventative actions.
Supports risk management activities (PFMEA, DFMEA) for new products.
Supports the development of metrics that report on the effectiveness of processes, status of improvement opportunities and progress against performance objectives to drive Continuous Improvement.
Supports regulatory submissions.
Supports multidisciplinary product, program and process improvement and development teams by providing information and compliance support to meet team goals.
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
Implements strategies in alignment with the overall business goals.
Provides technical support and training to all staff as related to quality practices.
Continues exposure to current quality practices through reading, conferences and training courses.
Education: Masters or Bachelor’s Degree in Engineering.
Experience: Bachelor’s or equivalent with 5+ years’ experience or Master’s with 3+ years experience in the regulated medical device industry or equivalent. In depth knowledge of regulatory requirements pertaining to instrumentation/medical device product lifecycle (e.g., ISO 13485, IEC 62304, ISO 14971, CE medical and IVD device directives, cGMP, etc.) is desirable.
Specialized knowledge: Knowledge of Quality System regulatory requirements. Knowledge of Health Canada and FDA regulations and guidance. Knowledge of European Device Directive, Safety requirements for Electrical Equipment, EMC Testing, etc. Knowledge in product labeling and promotional requirements. Thorough knowledge of product development process and design control of instruments.
Skills: Proven ability in coordinating efforts to implement and support Quality Management System requirements. Excellent technical report writing and strong ability to understand and analyze technical documents. Familiarity with Continuous Improvement concepts. Demonstrates the ability to apply scientific and technical knowledge, critical analyses and decision making skills to identify and resolve issues in areas including the Quality Management System. Excellent negotiation and problem solving skills. Strong project management and time management skills, and has worked closely with multiple internal and cross functional teams. The ability and the drive to work in a fast-paced environment and have a strong sense of project ownership are essential.
- Other characteristics such as personal characteristics: Comfortable making presentations before groups; ability to question and not be always satisfied with the status quo; willingness to learn and assume new responsibilities; good interpersonal skills; self motivated and independent work ethic; ability to handle multiple tasks in a fast paced environment.
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 significant career development opportunities.
To apply please select the apply button. You will then be directed to a login screen asking you to set up an account. You must set up an account in order to apply.Create an account by selecting the create account button. You will then be asked for your email and to create a password. Your Password must be eight characters long, contain at least one special character, one capital letter, and a number.Once you have created your password you will be asked to upload your resume. Uploading your resume will provide the ability to auto-populate your application with information from your resume. If you prefer to manually complete all of the fields in the application you can do this by clicking next. You can upload your cover letter as an attachment in the attachments screen. Thank you for your interest in STEMCELL!