Education & Qualifications:
- 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.
Duties & 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.