Tagline:
Contribute towards safe and effective products at a fast-growing medical technology company!
Type of Position:
Full Time
Location:
Kitchener, ON – In office presence required 3-days per week
Benefits:
RRSP with employer match, health benefits (effective day-1!), wellness benefit, learning & development opportunities, paid vacation, personal days, and sick days
The Company
Intellijoint Surgical develops effective and easy-to-use products to enhance surgeons’ care and patients’ lives. Today, Intellijoint technology lives in the operating room, helping surgeons improve implant positioning during hip and knee replacement surgeries. Our technology has been used in over 60,000 surgeries. We are seeking a Quality Assurance Analyst to join our Quality Assurance & Regulatory Affairs (QA/RA) team to help bring innovative technologies to the market.
The Position
Reporting to the Quality and Regulatory Affairs Manager, the Quality Assurance Analyst will support design, production, and process quality. The QA Analyst will contribute to the maintenance of the quality management system, ensuring compliance to industry standards and regulatory requirements. This role ensures that our products are safe and effective.
Main Duties:
Initiate, compose, review, and coordinate cross-functional stakeholders to manage quality issues (e.g. Corrective and Preventative Actions, Deviations, Non-Conformances, etc.)
Manage the documentation, investigation, and closure of complaints, including coordination with Regulatory Affairs to determine reportability, as required
Provide Operations support (e.g. approval of product records, inspections per material specifications) for the timely release and shipment of product
Assist in the maintenance of production processes according to requirements
Perform quality assurance activities related to audits, training, change control, document and record management
Prepare periodic reports to support the Quality Management System
Analyze sources of quality data to identify problem trends and opportunities for improvement
Assist in the maintenance, approval, and creation of quality documentation
Support planning and execution of design control deliverables
Maintain the content of the Design History File to regulatory and customer requirements
Participate in the development of new medical device technologies and sustaining engineering projects by providing insight into how quality requirements are met and maintained
Skills and Experience to Enable Success:
Post-Graduate diploma in Quality Assurance is an asset
3-5 years of relevant quality management experience in a regulated industry
Knowledge of Medical Device standards (ISO 13485, MDSAP, ISO 14971, IEC 60601)
Working knowledge of root cause analysis tools, CAPAs, Deviations, and NCRs
Experience working with software and/or electromechanical products
Familiarity with US, Canada, and International Medical Device Regulations
Attention to detail and appreciation for process
Why Join Us?
It is unrealistic for us to believe we will find someone who fits this position 100%
Strong support towards career development and growth
Work with innovative products that can improve surgical outcomes and enhance patient’s quality of life
Work alongside a highly talented and driven group of team members and colleagues organization wide
Work in an environment with high transparency and collaboration, along with lots of fun and social activities
Be ok with change and share in our excitement as we scale
Flexibility so that you can do your best both at work and outside of it
Intellijoint Surgical is committed to creating an accessible and inclusive work environment. It is our policy to recruit and select applicants solely on the basis of their qualifications. We are an equal opportunity employer that hires talent regardless of age, race, creed, colour, religion, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, or any other status or condition protected by applicable law. Intellijoint Surgical encourages applications from all qualified candidates.
Those in need of accommodation at any stage in the recruitment process should notify [email protected]. Any information received that relates to accommodation needs of a candidate will be addressed in a confidential manner.
