Quality Assurance

3 weeks ago

Kitchener, Canada Intellijoint Surgical Full time

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 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 procedural 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: 

Support product design, development and production via risk management, analysis, compliance, stakeholder engagement and process excellence.

Act as a key stakeholder and liaison with regulatory bodies in the submission of regulatory documents required for product approval and registration in various markets. 

Conduct comprehensive regulatory impact assessments for product changes, ensuring continuous compliance with international standards such as MDSAP, FDA QSR, EU MDR, etc. 

Contribute to and lead the development and improvement of internal processes and the quality management system by participating in audits, implementing advanced metrics, and analyzing data for continuous quality and regulatory enhancement. 

Lead the review and approval process for more complex product records and quality documentation, ensuring compliance with specified requirements. 

Contribute to the development and improvement of internal processes and the quality management system by participating in audits, implementing advanced metrics, and analyzing data for continuous quality and regulatory enhancement. 

Collaborate with the supply chain team to qualify suppliers, conduct audits, and ensure suppliers meet the required quality and regulatory standards. 

Conduct post-market surveillance activities, analyzing data from various sources (customer feedback, complaints, field reports) to identify potential product issues or trends, in line with regulatory requirements.

Coordinate the investigation and reporting of adverse events or other reportable incidents to regulatory authorities in compliance with global regulations. 

Skills and Experience to Enable Success:

Bachelor’s degree in a related field is required; a postgraduate certification in Regulatory Affairs and/or Quality Assurance is highly advantageous. 

3+ years of relevant experience in a regulated industry, with a strong focus on medical devices. 

Demonstrated experience in regulatory submissions, quality system management, and compliance with international medical device regulations and standards. 

Strong analytical skills, with the ability to interpret regulatory guidelines and integrate them into business processes. 

Proficient in using industry-standard software and systems, with a keen ability to adapt to new technologies. 

Strong communication skills, capable of effectively collaborating with diverse teams and championing compliance across the organization. 

Why join us? 

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. 

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