Quality Assurance
1 month ago
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.
Who referred you to this position? Enter their first and last name here.
Are you willing to relocate?
What's your citizenship / employment eligibility?
#J-18808-Ljbffr-
Quality Assurance Manager
2 months 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...
-
Quality Assurance Technician
2 weeks ago
Kitchener, Canada Waterloo Brewing Full time**WANT TO HELP US MAKE GREAT BEER?** Everybody has a part to play in making our award-winning beer. We believe in teamwork, superior quality, respect for each other, and supporting our local community. And you’ll be surprised what we make here.... From our own Waterloo craft beers (Landshark, Laker, Ciders) to the exciting beverages we make for other...
-
Quality Assurance Specialist
1 month ago
Kitchener, Canada BizLink elocab Ltd Full timeBizLink elocab Ltd. is a cable and harnessing manufacturing firm with branches throughout the world. As a global supplier of wires, optical fibers, cables and cable systems, we have been keeping pace with the developments of the last few decades as our world has become more densely networked. This has made us a sought-after partner and development supplier...
-
Quality Assurance Technician
1 week ago
Kitchener, Canada Waterloo Brewing Full time**Company Background** **Carlsberg Canada Inc. (CCI)** is the Canadian Division of Carlsberg Breweries A/S which is the World’s 3rd largest brewer and one of the fastest growing brewers in the World. With over 100 beer brands in our portfolio Carlsberg sells beer in over 140 countries world-wide while producing beer under license in over 40 countries. In...
-
Quality Assurance Tester
2 days ago
Kitchener, Canada Penad Pension Services Limited Full time**Who You Are** You are an experienced Quality Assurance Tester who is passionate about quality and discovering bugs in software. You are quick on your feet, able to document and track test results and have a keen eye for detail. You are an excellent communicator and competent in executing test cases. If this sounds like you, we invite you to join us as we...
-
Quality Assurance Manager
1 month ago
Kitchener, Canada Hearthside Food Solutions Full timeFounded 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 Manager
1 month ago
Kitchener, Canada Interbake Full timeFounded 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....
-
Software Quality Assurance Engineer
1 month ago
Kitchener, Canada FluidAI Medical Full timeCompany 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
1 month ago
Kitchener, Canada FluidAI Medical Full timeCompany 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
1 month ago
Kitchener, Canada FluidAI Medical Full timeCompany 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
7 days ago
Kitchener, Canada FluidAI Medical Full timeCompany 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
7 days ago
Kitchener, Canada FluidAI Medical Full timeCompany 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 Associate
1 month ago
Kitchener, Canada FluidAI Medical Full time**Job Title: Quality Assurance Associate** **Company Description**: FluidAI Medical is a medical device organization 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...
-
Professor, Quality Assurance
1 month ago
Kitchener, Canada Conestoga College Full timeRequisition Details **Job Title**: **Professor, Quality Assurance - Manufacturing & Management** **Requisition #**: **23-196** **Campus**: Doon **Department**: School of Workforce Development **Posting Date**: Tuesday, April 4, 2023 **Closing Date**: Tuesday, April 18, 2023 at 11:59 PM EST **Vacancy Type**: Academic - Full-time Academic...
-
Quality Assurance
1 month ago
Kitchener, Canada Intellijoint Surgical Full time**Tagline**: 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 **Benefits**: RRSP with employer match, health benefits (effective day-1!), wellness benefit, learning & development opportunities, paid vacation,...
-
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,...
-
Quality Assurance Coordinator
7 days ago
Kitchener, Canada BGIS Full time**Who We Are** **Job Summary**: As a member of the BGIS SCS Team, you will be responsible for a designated zone of job sites contracted for service. You will oversee the execution of duties and ensure all aspects of the client contract are being fulfilled, with an emphasis on quality control, health and safety & striving to exceed client...
-
Quality Assurance
1 month ago
Kitchener, Canada Intellijoint Surgical Full timeThe 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
1 month ago
Kitchener, Canada Intellijoint Surgical Full time**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...
-
Quality Assurance Coordinator
7 days ago
Kitchener, Canada Dare Foods Limited Full time**Dare Foods Limited** is a private, family owned portfolio of brands established in 1892. The Dare “Made Better” promise guides everything we do and comes to life through our portfolio of consumer-loved brands including Bear Paws, Breton, REALFRUIT, Boulangerie Grissol, and Whippet (to name just a few). Our head office is in Cambridge Ontario. We have...