Quality Assurance and Regulatory Affairs Analyst
6 months ago
**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
-
Quality Assurance
5 months 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,...
-
Quality Assurance Analyst
1 day ago
Kitchener, Canada Intellijoint Surgical Full timeThe Position Reporting to the Quality and Regulatory Affairs Manager, the Quality Assurance Analyst will support design, production, and process quality. The QA Analyst will contribute to the maintenance of the quality management system, ensuring compliance to industry standards and regulatory requirements. This role ensures that our products are...
-
Quality Assurance
5 months 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
5 months ago
Kitchener, Canada Intellijoint Surgical Full timeThe Position The QA/RA Coordinator will support design, production, and process quality. You will contribute to the maintenance of the quality system, ensuring compliance to industry standards and regulatory requirements. The successful candidate will ensure that Intellijoint Surgical products are safe and effective. As a snapshot, we are...
-
Medical Device Quality Assurance Specialist
5 hours ago
Kitchener, Ontario, Canada Intellijoint Surgical Full timeJob DescriptionThe Quality Assurance Analyst plays a crucial role in ensuring the quality and compliance of our medical devices.Main Responsibilities:Manage quality issues, including Corrective and Preventative Actions, Deviations, Non-Conformances, etc.Coordinate with Regulatory Affairs to determine reportability of complaints.Provide Operations support for...
-
Regulatory Financial Analyst
4 weeks ago
Kitchener, Canada Enova Power Corp. Full time**Position Summary** Enova Power Corp. is the trusted energy provider, dedicated to delivering safe and reliable energy solutions that power our communities forward. Serving more than 160,000 residential and business customers in the City of Kitchener and Waterloo, Township of Woolwich, Wilmot, and Wellesley, Enova Power Corp. is the 7th largest...
-
Regulatory Financial Analyst
3 weeks ago
Kitchener, Canada The MEARIE Group Full time**Regulatory Financial Analyst** Enova Power Corp. is the trusted energy provider, dedicated to delivering safe and reliable energy solutions that power our communities forward. Serving more than 160,000 residential and business customers in the City of Kitchener and Waterloo, Township of Woolwich, Wilmot, and Wellesley, Enova Power Corp. is the 7th...
-
Quality Assurance Support Analyst Expert
1 week ago
Kitchener, Ontario, Canada Sonova Full timeJob OverviewSonova is a global leader in innovative hearing solutions, with a presence in four businesses and various brands. As a Quality Assurance Support Analyst at Sonova, you will play a crucial role in ensuring that all products meet medical device standards and perform their intended function.Key ResponsibilitiesGather and review field performance...
-
Regulatory Financial Analyst
3 weeks ago
Kitchener, Canada The MEARIE Group Full timeRegulatory Financial AnalystEnova Power Corp. is the trusted energy provider, dedicated to delivering safe and reliable energy solutions that power our communities forward.Serving more than 160,000 residential and business customers in the City of Kitchener and Waterloo, Township of Woolwich, Wilmot, and Wellesley, Enova Power Corp. is the 7th largest...
-
Quality Assurance Support Analyst
2 weeks ago
Kitchener, Ontario, Canada Sonova Full timeSonova is a global leader in innovative hearing solutions, offering a range of products and services that improve the lives of individuals with hearing impairments. We operate through four businesses – Hearing Instruments, Audiological Care, Consumer Hearing, and Cochlear Implants – and our core brands include Phonak, Unitron, AudioNova, Sennheiser...
-
Quality Assurance Analyst
6 months ago
Kitchener, Canada CBI Health Full time**Quality Assurance Analyst - Kitchener, ON (Remote)** FOCUS Assessments looking for Full-time, working remotely (may be required on site in Kitchener from time to time for meetings or training). **About this opportunity**: **Take an inside look at what you’ll do each day**: - Review Independent Medical Evaluation (IME) reports for clarity, objectivity,...
-
Quality Assurance Technical Specialist
3 weeks ago
Kitchener, Ontario, Canada Sonova Full timeQuality Assurance Support AnalystSonova, a global leader in innovative hearing solutions, seeks a Quality Assurance Support Analyst to ensure compliance with medical device standards and optimal product performance.Responsibilities:Collect and analyze field performance data, prepare monthly reports, and track trends in product reliability and customer...
-
Quality Assurance Manager
5 months 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 Support Analyst
4 months ago
Kitchener, Canada Sonova Full timeSonova is a global leader in innovative hearing solutions: from personal audio devices and wireless communication systems to audiological care services, hearing aids and cochlear implants. We operate through four businesses – Hearing Instruments, Audiological Care, Consumer Hearing and Cochlear Implants – and the core brands Phonak, Unitron, AudioNova,...
-
Quality Assurance Manager
5 months 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....
-
Quality Assurance/operations Manager
2 months ago
Kitchener, Canada Pano Cap Canada Limited Full time**Job Overview** Pano Cap Canada Limited is a Plastic Injection Molding company located in Kitchener, Ontario who manufactures plastic closures for the food, pharmaceutical, nutraceutical, beverage and consumer product markets. Founded in 1967 as a sister company to a metal cap manufacturer in Northern Germany, Pano Cap Canada eventually converted to an all...
-
Food Safety and Quality Assurance Manager
6 months ago
Kitchener-Waterloo, Canada Heidelberg Foods Ltd. Full timeFood Safety and Quality Assurance Manager is on the on-site food safety and regulatory authority at the Reitzel Place processing facility, the Kitchener cold storage facility and any additional or replacement facilities. The position has the primary responsibility of driving the food safety systems of the facilities by developing, modifying, and maintaining...
-
Quality Electrical Technician
3 weeks ago
Kitchener, Ontario, Canada Brock Solutions Full timeQuality Electrical Test Technician Job Description Brock Solutions is a customer-centric, performance-driven, team-based engineering solutions and electrical panel manufacturing company. We are currently hiring for a full-time, day shift Quality Electrical Test Technician at our Kitchener location. The Quality Electrical Test Technician will be...
-
Quality Assurance Specialist
1 week ago
Kitchener, Ontario, Canada Intellijoint Surgical Full timeJob SummaryWe are seeking a detail-oriented and organized Quality Assurance Specialist to support design, production, and process quality at Intellijoint Surgical. The successful candidate will contribute to the maintenance of the quality system, ensuring compliance to industry standards and regulatory requirements.About the RoleThis is an excellent...
-
Quality Assurance Support Specialist
1 month ago
Kitchener, Ontario, Canada Sonova Full timeSonova is a global leader in innovative hearing solutions, operating through four businesses – Hearing Instruments, Audiological Care, Consumer Hearing, and Cochlear Implants – and the core brands Phonak, Unitron, AudioNova, Sennheiser, and Advanced Bionics.As a Quality Assurance Support Analyst, you will be responsible for ensuring that all products...