Quality Assurance
2 weeks ago
*Tagline:
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Contribute towards safe and effective products at a fast-growing medical technology company
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Type of Position:*
Full Time (In-office presence required minimum 3-days per week)
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Location:*
Kitchener, ON
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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 45,000 surgeries - helping us to gain real-world feedback from patients and surgeons to improve our products. We are seeking a **Quality Assurance & Regulatory Affairs (QA/RA)** **Coordinator** to join our Q**uality Assurance & Regulatory Affairs (QA/RA) **team to help bring innovative technologies to the market. We are a growing organization that is looking to expand our QA/RA team.
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The Position*
As a **_snapshot, _**we are looking for someone who:
- Is very detail oriented, organized and diligent in adhering to policies and procedures
- Is able to pivot their focus and “switchgears” to a new task, when priority asks arise
- Has effective and clear written and verbal communication skills
- Has experience working in a regulated environment
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Main Duties:*
- Operate within all Intellijoint Surgical processes and procedures
- Schedules and assists with the execution of quality maintenance activities
- Assists the submission and maintenance of regulatory documentation
- Support the maintenance of quality dashboards using Atlassian, SharePoint and/or eQMS tools
- Support the internal and external Intellijoint Audit Program
- Work in collaboration with internal stakeholders to assist the maintenance, approval and creation of quality documentation
- This may include Certificates of Conformance, RMAs, NCRs, etc.
- Review and approve product records for final release according to defined requirements and specifications
- Supports the QA/RA department with the quality onboarding of Intellijoint Surgical staff
- Including assisting in documenting and tracking employee training
- Assists with electronic document control systems
- Assists with the coordination and execution of quality issues, as applicable
- Actively participates in continuous improvement activities
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Skills and Experience to Enable Success:*
- Post Secondary Diploma
- 1-2 years relevant experience in a regulated industry
- Experience working in an administrative role requiring extreme attention to detail
- Strong written and verbal communication skills
- Organized and able to schedule reoccurring maintenance activities to maintain compliance
- Experience working in a medical device environment (ISO 13485, FDA QSR, EU MDD/MDR, etc.) is an asset
- Experience working with tools such as MS Office, Google Workspace, Dropbox and Atlassian is an asset
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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 on innovative products that can 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._PJYngaSjcJ
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