Quality Assurance

3 weeks ago

Kitchener ON, Canada Intellijoint Surgical Inc Full time
Quality Assurance & Regulatory Affairs Analyst

Contribute towards safe and effective products at a fast-growing medical technology company

Type of Position:

Full Time

Location:

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

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 55,000 surgeries. 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 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.

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.

Intellijoint Surgical encourages applications from all qualified candidates. Those in need of accommodation at any stage in the recruitment process should notifyhr@intellijointsurgical.com . Any information received that relates to accommodation needs of a candidate will be addressed in a confidential manner.

#J-18808-Ljbffr

  • Quality Assurance Manager

    1 month ago

    Kitchener, Canada Zekelman Industries Full time

    **Job Description**: Z-Modular, a division of Zekelman Industries, seeks a **Quality Assurance Manager** for our location in Kitchener, ON. This person will work with other Quality Assurance Managers at various locations to ensure implementation and maintenance of a consistent quality system throughout the Zekelman Industries...

  • Software Quality Assurance Engineer

    3 weeks ago

    Kitchener, ON, Canada FluidAI Medical Full time

    Company Description: FluidAI Medical is creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at their onset. Our clinically validated platform sensing technology augments existing wound drains and catheters, providing healthcare providers with a smart...

  • Quality Assurance Supervisor

    3 weeks ago

    Kitchener, ON, Canada Intellijoint Surgical Inc Full time

    Quality Assurance & Regulatory Affairs Coordinator Contribute towards safe and effective products at a fast-growing medical technology company! Full Time (In-office presence required 3-days per week) RRSP with employer match, health benefits (effective day-1!), Today, Intellijoint technology lives in the operating room, helping surgeons improve implant...

  • Software Quality Assurance Engineer

    6 days ago

    Kitchener, ON, Canada FluidAI Medical Full time

    FluidAI Medical is creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at their onset. Our clinically validated platform sensing technology augments existing wound drains and catheters, providing healthcare providers with a smart monitoring tool that can...

  • Software Quality Assurance Engineer

    6 days ago

    Kitchener, ON, Canada FluidAI Medical Full time

    FluidAI Medical is creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at their onset. Our clinically validated platform sensing technology augments existing wound drains and catheters, providing healthcare providers with a smart monitoring tool that can...

  • Quality Assurance

    2 weeks ago

    Kitchener, ON, Canada Intellijoint Surgical Inc Full time

    Quality Assurance & Regulatory Affairs Analyst Contribute towards safe and effective products at a fast-growing medical technology company! Type of Position: Full Time Location: Kitchener HQ – In office presence required 3-days per week RRSP with employer match, health benefits (effective day-1!), wellness benefit, learning & development...

  • Software Quality Assurance Engineer

    3 weeks ago

    Kitchener, Canada FluidAI Medical Full time

    Company Description: FluidAI Medical is creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at their onset. Our clinically validated platform sensing technology augments existing wound drains and catheters, providing healthcare providers with a smart...

  • Software Quality Assurance Engineer

    3 weeks ago

    Kitchener, Canada FluidAI Medical Full time

    Company Description: FluidAI Medical is creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at their onset. Our clinically validated platform sensing technology augments existing wound drains and catheters, providing healthcare providers with a smart...

  • Software Quality Assurance Engineer

    3 weeks ago

    Kitchener, Canada FluidAI Medical Full time

    Company Description: FluidAI Medical is creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at their onset. Our clinically validated platform sensing technology augments existing wound drains and catheters, providing healthcare providers with a smart...

  • Quality Assurance

    3 weeks ago

    Kitchener, ON, Canada Intellijoint Surgical Inc Full time

    Quality Assurance & Regulatory Affairs Coordinator 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: RRSP with employer match, health benefits (effective day-1!), wellness benefit, learning & development opportunities, paid...

  • Software Quality Assurance Engineer

    1 month ago

    Kitchener, ON, Canada FluidAI Medical Full time

    Company Description: FluidAI Medical is creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at their onset. Our clinically validated platform sensing technology augments existing wound drains and catheters, providing healthcare providers with a smart...

  • Quality Assurance Manager

    4 weeks ago

    Kitchener, ON, Canada Hearthside Food Solutions LLC Full time

    Founded in 2009 and headquartered in Downers Grove, IL we are a world-class contract manufacturer producing wholesome baked goods, snacks and packaged foods for many of the world’s leading food companies. As one of the largest and fastest growing food co-manufacturing companies in the US, we are the proud owner and operator of over 35 facilities globally....

  • Quality Assurance

    4 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...

  • Quality Assurance Technologist

    3 days ago

    Etobicoke, ON, Canada Spectral Medical Inc. Full time

    POSITION: Quality Assurance TechnologistSITE: Spectral Medical Inc.DEPARTMENT: Quality Assurance and Regulatory AffairsREPORTS TO: Head of Quality Assurance and Regulatory AffairsHOURS: 37.5 per weekRATE: $31.79 hourly SCHEDULE: Mon-Fri (business hours)STATUS : Permanent, Full-Time (Hybrid)COMPANY OVERVIEW:Spectral Medical Inc. (SMI) is at the forefront of...

  • Quality Assurance Technologist

    3 days ago

    Etobicoke, ON, Canada Spectral Medical Inc. Full time

    POSITION: Quality Assurance TechnologistSITE: Spectral Medical Inc.DEPARTMENT: Quality Assurance and Regulatory AffairsREPORTS TO: Head of Quality Assurance and Regulatory AffairsHOURS: 37.5 per weekRATE: $31.79 hourly SCHEDULE: Mon-Fri (business hours)STATUS : Permanent, Full-Time (Hybrid)COMPANY OVERVIEW:Spectral Medical Inc. (SMI) is at the forefront of...

  • Quality Assurance Manager

    2 days ago

    Orillia, ON, Canada Polyethics Industries Inc. Full time

    Company DescriptionPolyethics Industries Inc. specializes in manufacturing environmentally friendly polyethylene film and bags for the consumer and industrial markets. We manufacture a full range of HDPE, LDPE, and LLDPE products, including degradable trash bags, food storage bags, printed film and bags, and more. As the first manufacturer to use 100%...

  • Quality Assurance Manager

    2 days ago

    Orillia, ON, Canada Polyethics Industries Inc. Full time

    Company DescriptionPolyethics Industries Inc. specializes in manufacturing environmentally friendly polyethylene film and bags for the consumer and industrial markets. We manufacture a full range of HDPE, LDPE, and LLDPE products, including degradable trash bags, food storage bags, printed film and bags, and more. As the first manufacturer to use 100%...

  • Quality Assurance

    1 hour ago

    Vaughan, ON, Canada State Window Corporation Full time

    State Window Corporation, Awarded Canada's Best Managed Company of 2021, 2022 , and 2023 is a PROFIT 500 manufacturing and construction company located in Vaughan, ON.Together, we manufacture, design and install window wall, curtain wall, metal panels, glass and railing systems for high rise condominiums. We are looking for individuals who are...

  • Quality Assurance Manager

    7 days ago

    Woodbridge, ON, Canada Imploy Full time

    Position Summary:The Quality Assurance Manager is responsible for ensuring that all products and services produced by the company comply with the highest standards of quality, safety, and reliability. This includes developing and implementing a comprehensive quality assurance system to monitor performance, identify and resolve problems, and ensure that all...

  • Quality Assurance Manager

    7 days ago

    Woodbridge, ON, Canada Imploy Full time

    Position Summary:The Quality Assurance Manager is responsible for ensuring that all products and services produced by the company comply with the highest standards of quality, safety, and reliability. This includes developing and implementing a comprehensive quality assurance system to monitor performance, identify and resolve problems, and ensure that all...