Quality Assurance and Regulatory Affairs Analyst

7 months ago

Kitchener, Canada Intellijoint Surgical Full time

**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:

- 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
- Effectively communicates both written and verbal; clear, concise, and responsive
- Thoughtful approach to decision-making with high agency

**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
- 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.
- 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 system administration of Quality Management System software.
- Support internal teams to implement quality control tools and processes to improve compliance.
- Support investigations into Corrective and Preventive Actions, Field Failures, and Production Non-Conformances.
- Communicate with suppliers regarding performance and maintain accurate supplier files.
- Collaborate with cross-functional teams and interface with external parties to meet quality requirements within project timelines.
- Work within ISO 13485, FDA, and MDSAP requirements.

**Skills and Experience to Enable Success**:

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

**Why Join Us?**
- 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 on innovative products that 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._o2Yjg

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