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.Job Description Duties and ResponsibilitiesQuality Management System Support:
Project Quality Assurance/Quality Engineering:
- Maintains systems and procedures and champion implementation of quality assurance activities in compliance with applicable medical device regulations and standards such as 21 CFR part 820, ISO 13485, ISO 14971, IEC 60601-1 etc.
- Reviews, approves and follows up on Engineering Changes (ECs), as required.
- Conducts supplier evaluation, supplier qualifications and supports SCAR and other supplier quality activities for instrumentation components.
- Supports day-to-day QA investigations on product complaints and non-conformances. Determines root cause, evaluates and implements preventive and corrective actions for quality problems.
- Monitors and reports on effectiveness of internal and external corrective and preventive action activities.
- 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 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 implementing quality by design and design control for medical devices.
- Reviews/assists with the preparation of Market Spec and Product Spec, Review Drawings, manufacturing procedures, and test procedures.
- Confirms compliance of specifications with international standards;
- Confirms complete/sufficient rationale/justification for Specs/Test methods;
- Confirms specifications developed to address user/device/process risks;
- Evaluates the need for inspection points in manufacturing process flow and writes inspection procedures.
- Monitors and supports supplier related activities, including evaluation/auditing, qualification, performance rating, corrective actions, etc.
- Assists with prep of Regulatory submissions: 510(k), Technical File
- Creates or assists with risk management activities such as UFMEA, DFMEA, PFMEA.
- Review of Product/Process Verification/Validation: Confirms DV/V testing addresses all Market Spec and Product Spec requirements to appropriate sample sizes;
- Assists with IQ/POQ/PQ/PPQ strategy/execution.
- Represent Quality Assurance in design review of new and redesigned products.
- 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.).
- 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.
- 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.
- 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.
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.
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.
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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!