Quality Assurance And Regulatory Affairs Analyst

Tagline:

Contribute to the safety and compliance of innovative products at a growing medical technology company!

Type of Position:

Full Time

Location:

Kitchener HQ – In office presence required minimum 3-days per week

Benefits:

RRSP with employer match, health/dental/vision package, 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 50,000 surgeries - helping us to gain real-world feedback from patients and surgeons to improve our products. We are seeking a Quality Assurance & Regulatory Affairs (QARA) Analyst to join our QARA team to help bring innovative technologies to the market.

The Position

As part of the Quality Assurance and Regulatory Affairs (QA/RA) Team, the QA/RA Analyst plans and implements quality assurance and regulatory affairs activities required for the timely completion and sale of Intellijoint Surgical medical devices in a regulated environment. As an integral member of the team, the QA/RA Analyst collaborates with internal and external parties, ensuring compliance with our internal Quality Management System (QMS) requirements.

As a snapshot, we are looking for someone who:

• Effectively communicates both written and verbal; clear, concise, and responsive
• Thoughtful approach to decision-making with high agency
• Thrives in a policy and procedurally driven environment; detail oriented, organized, and diligent in adherence to policies and procedures
• Nimble to adjust to priority tasks as they arise
• A continuous learner that builds on their existing knowledge of medical device and biomedical technology regulations

Main Duties:

• Create and revise quality procedures (Standard Operating Procedures) to enable smooth collaboration between teams, while maintaining compliance to the IJS QMS and external quality and regulatory standards
• Participate in quality and regulatory audits, including gathering data, preparing for audits, and resolving audit observations.
• Perform or support internal audits and supplier (on-site) audits and routine supplier evaluations.
• Support internal teams to implement quality control tools and processes to improve compliance.
• Collaborate with cross-functional teams and interface with external parties to meet quality requirements within project timelines.
• Support system administration of Quality Management System software.
• Support investigations into Corrective and Preventive Actions, Field Failures, and Production Non-Conformances.
• Review documentation and records for accuracy and compliance to internal and external quality procedures, including nonconforming materials, complaints, CAPAs, purchase orders, change orders, and device history records.
• Support implementation of system to measure and analyze key quality metrics.
• Work within ISO 13485, FDA, and MDSAP requirements.
• Communicate with suppliers regarding performance and maintain accurate supplier files.

Skills and Experience to Enable Success:

• 2-3 years of experience working in a regulated environment compliant with ISO 13485/MDSAP and/or FDA 21 CFR 820.
• High agency attitude.
• Experience working within a Quality Management System (QMS)
• Skilled in document review, with attention to detail
• Strong organizational, time management, and prioritization skills.
• Experience with performing or supporting internal audits and supplier (on-site) audits
• Post-secondary degree or certification in quality assurance and/or regulatory affairs.
• Keen interest in medical devices and biomedical technology

Why Join Us?

• Work alongside a highly talented and driven group of team members and colleagues’ organization wide
• Flexibility so that you can do your best both at work and outside of it
• Work on innovative products that improve surgical outcomes and enhance patient’s quality of life
• It is unrealistic for us to believe we will find someone who fits this position 100% - interested? Apply!
• Strong support towards career development and growth
• 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

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 

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