Quality Assurance Analyst

Intellijoint Surgical Inc.; Kitchener; On-site; CAD 70,000 - 90,000; Full time

Job summary

A fast-growing medical technology company is seeking a Quality Assurance Analyst to join their QA/RA team. This role focuses on maintaining the quality management system and ensuring compliance with industry standards, contributing to safe and effective medical device solutions.

Benefits

RRSP with employer match

Health benefits (effective day-1!)

Paid vacation

Personal days

Wellness benefit

Learning & development opportunities

Sick days

Qualifications

• 3-5 years of relevant quality management experience in a regulated industry.
• Knowledge of Medical Device standards (ISO 13485, MDSAP, ISO 14971, IEC 60601).
• Familiarity with US, Canada, and International Medical Device Regulations.

Responsibilities

• Initiate and manage quality issues including CAPAs and Non-Conformances.
• Support Operations for timely product release and shipment.
• Prepare periodic reports to support the Quality Management System.

Skills

Attention to detail

Process appreciation

Education

Post-Graduate diploma in Quality Assurance

Tools

Root cause analysis tools

CAPAs

Deviations

NCRs

Job description

Tagline:

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

Type of Position:

Full Time

Location:

Kitchener, ON– In office presence required 4-days per week

Benefits:

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 60,000 surgeries. We are seeking a Quality Assurance Analyst to join our Quality Assurance & Regulatory Affairs (QA/RA) team to help bring innovative technologies to the market.

The 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 safe and effective.

Main Duties:

• Initiate, compose, review, and coordinate cross-functional stakeholders to manage quality issues (e.g. Corrective and Preventative Actions, Deviations, Non-Conformances, etc.)

• Manage the documentation, investigation, and closure of complaints, including coordination with Regulatory Affairs to determine reportability, as required

• Provide Operations support (e.g. approval of product records, inspections per material specifications) for the timely release and shipment of product

• Assist in the maintenance of production processes according to requirements

• Perform quality assurance activities related to audits, training, change control, document and record management

• Prepare periodic reports to support the Quality Management System

• Analyze sources of quality data to identify problem trends and opportunities for improvement

• Assist in the maintenance, approval, and creation of quality documentation

• Support planning and execution of design control deliverables

• Maintain the content of the Design History File to regulatory and customer requirements

• Participate in the development of new medical device technologies and sustaining engineering projects by providing insight into how quality requirements are met and maintained

Skills and Experience to Enable Success:

• Post-Graduate diploma in Quality Assurance is an asset

• 3-5 years of relevant quality management experience in a regulated industry

• Knowledge of Medical Device standards (ISO 13485, MDSAP, ISO 14971, IEC 60601)

• Working knowledge of root cause analysis tools, CAPAs, Deviations, and NCRs

• Experience working with software and/or electromechanical products

• Familiarity with US, Canada, and International Medical Device Regulations

• Attention to detail and appreciation for process

Why Join Us?

• It is unrealistic for us to believe we will find someone who fits this position 100%

• Strong support towards career development and growth

• Work with innovative products that can improve surgical outcomes and enhance patient’s quality of life

• Be ready to innovate!

• 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 [e-mail]. Any information received that relates to accommodation needs of a candidate will be addressed in a confidential manner.