Quality Assurance Team Leader - Medical Device
Baylis Medical is a leading developer, manufacturer and supplier of high-technology medical devices for cardiology, radiology and spine products. Baylis Medical products are marketed in over 65 countries. Our goal is to conceive, develop, manufacture, and sell state-of-the-art medical products that will improve the lives of people around the world. To assist us in realizing our goal, Baylis Medical adheres to four main guiding principles: Technological Leadership, Employee Development, Customer Service and Corporate Social Responsibility.
Our Quality team is growing and we are seeking a Quality Assurance Team Leader to lead a cross-functional department. This position will allow application of a seasoned QA professional's knowledge in planning, conducting, and leading quality management projects including the assessment of new and changed standards, regulations and requirements, update of the Quality System and the modification of established guidelines. This is a great opportunity that allows the capacity for independent accomplishment and coordination of challenging yet rewarding assignments.
Reports to: Quality Manager.
Snapshot of Responsibilities
- Lead a team of Quality Assurance Professionals responsible for complaint handling, corrective and preventive action, internal audit, external audit, document control, standards implementation, recall management, and quality system procedures
- Coordinate and collate key performance indicators of the quality system
- Make independent studies, analyses, interpretations and conclusions; Results and conclusions are reviewed primarily for process and soundness of judgment; Assign and outlines work; advises and reviews work for adequacy to Quality requirements and regulations.
- Ensure the adequacy of training in Quality Assurance
- Coordinate significant investigations especially escalations of performance issues with customers; Interface with engineering and production on quality related issues in quality system processes
- Participate in internal audits as an audit team leader; participates in supplier audits as an audit team leader; Participates in external audits as an audit escort
- Conduct project planning with departmental authorities; Plan, coordinate and implement improvements of Quality procedures processes (e.g. Document control, record control, internal audits, management review, measurement and feedback, environmental controls, etc).
- Plan and review work of others and conduct employee evaluations and career development planning; Conduct some administrative management functions (e.g. Vacation request approvals). Supervision may call for recommendations concerning selection, training, rating and discipline of staff.
- Comply with the Health & Safety policies of the company and inform management of unsafe working conditions
- Other duties as required
- Bachelor's Degree in a related field of Science required
- Training or certification in Quality field is required
- Brings minimum 5-8 years related working experience in Quality Assurance roles with at least 2-5 years people management experience required. Experience from a regulated industry such as medical device, aeronautical or pharma highly preferred
- Demonstrated competence in ISO 13485, ISO 14971, 21 CFR 820, CMDCAS and EU MDD, other relevant jurisdictional regulations and ISO 19011
- Demonstrated competence as a Senior Quality Assurance Analyst or equivalent
- Proficient in MS Office
- Excellent analytical and communication skills (presentation, written and oral)
- Strong interpersonal skills
- Excellent organization and time management skills
- Demonstrated proficiency in project management
- Possible need to travel to visit suppliers
- Proficient in Statistical and Analytical Techniques
- Opportunity for growth
- Competitive salary and benefits
- RRSP matching
- Flexible start times
- On site gym facility
Baylis Medical is an equal opportunity employer and encourages applications from all qualified individuals. Please inform us if you require any accommodations during the recruitment process.
While we thank all applicants, only those being considered for an interview will be contacted.
Meet Some of Baylis Medical's Employees
Senior R&D Engineer
Linus and his team develop new medical devices, overseeing and reviewing the technical challenges involved while also communicating with other departments in order to get products to market.
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