Quality Assurance & Regulatory Affairs Coordinator
Tagline: | Contribute towards safe and effective products at a fast-growing medical technology company! |
Type of Position: | Full Time (In-office presence required 3-days per week) |
Location: | Kitchener, ON |
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 & Regulatory Affairs (QA/RA) Coordinator to join our Quality Assurance & Regulatory Affairs (QA/RA) team to help bring innovative technologies to the market.
The Position
The QA/RA Coordinator will support design, production, and process quality. You will contribute to the maintenance of the quality system, ensuring compliance to industry standards and regulatory requirements. The successful candidate will ensure that Intellijoint Surgical products are safe and effective.
As a snapshot, we are looking for someone who:
Is very detail oriented, organized and diligent in adhering to policies and procedures
Is able to pivot their focus and “switchgears” to a new task, when priority asks arise
Has effective and clear written and verbal communication skills
Has experience working in a regulated environment
Main Duties:
Assists with the execution (as applicable) of quality maintenance activities.
Assist the maintenance, approval, and creation of quality documentation.
This may include Certificates of Conformance, RMAs, NCRs, etc.
Supports the QA/RA department with the quality onboarding of Intellijoint Surgical staff.
Assists with electronic document control systems, as applicable.
Assist in documenting and tracking employee training.
Support the maintenance of quality dashboards using Atlassian, Sharepoint, and/or eQMS tools.
Assists with the coordination and execution of quality issues (as applicable).
Support the internal and external Intellijoint Audit Program.
Review and approve product records for final release according to defined requirements and specifications.
Operate within all Intellijoint Surgical processes and procedures, and actively participates in continuous improvement activities.
Assists the submission and maintenance of regulatory documentation.
Skills and Experience to Enable Success:
Post Secondary Diploma.
1-2 years relevant experience in a regulated industry.
Strong communication skills along with extreme attention to detail.
Experience working in a medical device environment (ISO 13485, FDA QSR, EU MDD/MDR, etc.) is an asset.
Experience working with tools such as MS Office, and Google Workspace, Dropbox, and Atlassian is an asset.
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 on 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.