The Role
Supports the Quality Assurance team with document numbering, creation, revision control, change-request reviews, production and inspection record verification, filing, data entry, QMS reporting, and computerized system validation. The role escalates documentation and quality issues, maintains quality logs, assists with audits, and trains employees on document control and quality procedures. It requires strong organization, attention to detail, Microsoft Office and SharePoint skills, and collaboration across departments in an on-site medical device manufacturing environment.
Summary Generated by Built In
Specialisterne is Recruiting!
Specialisterne connects qualified neurodivergent candidates to employment opportunities in numerous industries and sectors in Canada and the US.
To be eligible to apply, you must have experienced barriers getting and/ or maintaining meaningful employment and you identify with one of the following:
Specialisterne is proud to partner with Traferox on a Neurodiversity Hiring Initiative.
Summary:
Title: Quality and Document Control Associate
Employment Type: Full-Time/Contract
Hours: Expected Hours
Location: Mississauga, ON (On-Site)
Salary: $50,000-$60,000
Target Start Date: September 2026
About this Role:
The Quality and Document Control Associate is a member of the Quality Assurance team at Traferox and interacts with all other departments in the company to assist with document and record creation, review and approval processes, filing and record-keeping. Document and record control is an essential part of medical device manufacturing.
Essential Tasks - In this job, you will:
General Skills and Abilities - You have:
Digital/Technical Skills & Tools - You are:
Education/Knowledge - You:
Experience (Professional, Academic, Personal) - You:
Additional Information:
Here’s how frequently the following types of communication and interaction are required to perform the job:
Here’s what can employees find stressful about this job:
Specialisterne connects qualified neurodivergent candidates to employment opportunities in numerous industries and sectors in Canada and the US.
To be eligible to apply, you must have experienced barriers getting and/ or maintaining meaningful employment and you identify with one of the following:
- Autism (including Asperger’s and PDD-NOS)
- Attention Deficit/Hyperactivity Disorder (ADHD) or Attention Deficit Disorder (ADD)
- Learning Disability (e.g., dyslexia, dyscalculia, dysgraphia)
- Intellectual Disability
- Obsessive Compulsive Disorder (OCD)
- Tourette Syndrome
Specialisterne is proud to partner with Traferox on a Neurodiversity Hiring Initiative.
Summary:
Title: Quality and Document Control Associate
Employment Type: Full-Time/Contract
Hours: Expected Hours
Location: Mississauga, ON (On-Site)
Salary: $50,000-$60,000
Target Start Date: September 2026
About this Role:
The Quality and Document Control Associate is a member of the Quality Assurance team at Traferox and interacts with all other departments in the company to assist with document and record creation, review and approval processes, filing and record-keeping. Document and record control is an essential part of medical device manufacturing.
Essential Tasks - In this job, you will:
- Assist all company employees with document numbering, creation, and revision control processes.
- Review document and component change requests to ensure completeness and accurate information.
- Review all production purchase requests to cross-check component part numbers, revision, and vendor against the approved parts database.
- Review incoming inspection records for completeness. Route forms for electronics signatures. Escalate quality issues in cases of documentation discrepancies or non-conforming parts.
- Review production forms and other quality records for completeness and adherence to good documentation practices.
- File quality records as physical or electronic records and retrieve files as requested.
- Follow up on open tasks and issues and ensure update of quality system lists and logs.
- Prepare monthly and ad hoc QMS and project reports.
- Assist in data entry tasks for document and product change requests.
- Assist in computer system validation activities.
- Provide training and guidance to employees on document and change control, quality control procedures, and best practices to promote a culture of quality and continuous improvement.
- Other duties as assigned.
General Skills and Abilities - You have:
- Excellent attention to detail.
- Ability to read and interpret instructions and communicate deficiencies effectively to other team members
- Strong work ethic and passion to learn and contribute as a member of a high performing team
- Organization skills
- Proficient typing and editing skills
- Ability to handle and prioritize multiple projects simultaneously.
Digital/Technical Skills & Tools - You are:
- Between Basic and Intermediate skill level with Microsoft Office programs (Word, Excel, PowerPoint) and SharePoint
- Ability to become proficient in Electronic Document Management Systems (EDMS) and using electronic signatures (Adobe sign)
- Basic - e.g., I can do this in simple situations with close or extensive guidance
- Basic to Intermediate
- Intermediate - e.g., I can do this in most situations, with occasional guidance
- Intermediate to expert
- Expert - e.g., I can do this in exceptionally difficult situations with no guidance and I can be a key resource for others.
Education/Knowledge - You:
- College diploma or Bachelor’s degree in Science or a related field
- Nice to have (but not required):
- Certification in a quality-related or manufacturing discipline
Experience (Professional, Academic, Personal) - You:
- Nice to have (but not required):
- 1-2 years experience in a quality-regulated environment (e.g., medical devices/pharmaceutical manufacturing, automotive, aerospace, etc.)
- Experience in start-ups requiring the ability to work on multiple tasks and take initiative in continuous improvement of the quality system.
- Experience working with computerized quality management / PLM systems
Additional Information:
Here’s how frequently the following types of communication and interaction are required to perform the job:
- Oral communication: Daily
- Email communication: Daily
- Instant messaging: Daily, MS Teams
- Telephone Communication: N/A
- Video communication: Weekly, MS Teams
- Interacting with supervisors: Daily
- Interacting with peers: Hourly
- Interacting with customers: N/A
- Selling or influencing others: N/A
- Training or teaching others: Weekly
Here’s what can employees find stressful about this job:
- Working in a fast-paced environment to meet time sensitive requests
- Managing changing priorities and requests from multiple teams at the same time
- Producing specific records during audit situations to validate information is accurate
- The quality department is integral to the organization and interacts with all other departments, providing insight into all aspects of the company
- Working in the field of organ transplantation, you are part of a team that makes organs more accessible to those who need them
Skills Required
- Eligibility for Specialisterne’s neurodiversity hiring initiative, including experienced employment barriers and identification with autism, ADHD/ADD, learning disability, intellectual disability, OCD, or Tourette Syndrome
- College diploma or Bachelor’s degree in Science or a related field
- Excellent attention to detail
- Ability to read and interpret instructions and communicate deficiencies effectively
- Strong work ethic and willingness to learn and contribute
- Organization skills
- Proficient typing and editing skills
- Ability to handle and prioritize multiple projects simultaneously
- Basic to intermediate proficiency with Microsoft Word, Excel, PowerPoint, and SharePoint
- Ability to become proficient with electronic document management systems and electronic signatures
- Certification in a quality-related or manufacturing discipline
- 1-2 years of experience in a quality-regulated environment
- Experience in startups and continuous quality-system improvement
- Experience with computerized quality management or PLM systems
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
Specialisterne USA is a charitable, not-for-profit organization focused on bridging neurodivergent job seekers and employers, supporting the integration of neurodiverse talent into the workforce and building inclusive organizations.
