Skip to main content
Post your resume and find your next job on Indeed!

Certification Specialist Medical Devices jobs in Ontario

Sort by: -
    • Certification constraints (Transportation, Aerospace, Medical Devices, Nuclear, Cybersecurity).
    • Support and participate as needed in internal and external…
    • View all Hitachi jobs - Toronto jobs - Quality Assurance Analyst jobs in Toronto, ON
    • Salary Search: Technical Specialist, Quality Assurance salaries in Toronto, ON
    • See popular questions & answers about Hitachi
    • Hands-on engineering system/software development or Quality Assurance experience in complex system environments with certification constraints (Transportation,…
    • The Quality Assurance Specialist is responsible for creating and maintaining device master records (DMRs), qualifying and conducting vendor evaluations,…
    • The product portfolio covers Glaucoma surgical device and Retina.
    • Provide product knowledge and technical troubleshooting support specific to device and…
    • The Quality Assurance Specialist is responsible for managing and coordinating the Quality Management System, and providing quality leadership for Gamma…
    • Trade compliance, export compliance, or customs certification such as CCS, CTCS, CUSECO, export compliance certification, or similar credential is an asset.
    • Experience providing patient instruction on the use and care of medical devices or therapeutic products.
    • Prepare and submit Assistive Devices Program (ADP)…
    • P. Eng certification or in progress.
    • Knowledge of network hardware, including servers, routers, and other computer devices.
    • Understanding of TCP/IP and LAN/WAN.
    • CompTIA A+, Microsoft certifications, or other relevant technical certifications.
    • Experience troubleshooting desktops, laptops, printers, mobile devices, and…
    • Zero AEs run a discovery call or demo with a customer without passing certification — no exceptions.
    • Establish a certification renewal cycle and keep the…
    • Conduct manual penetration testing on web applications, network devices, and other systems.
    • Preferred, but not required - one or more relevant certifications…
    • Health & Wellness— Comprehensive medical, dental, and vision coverage tailored to your local needs.
    • Maintain user accounts, permissions, device records, and…
    • Define and manage safety evidence for certification, ensuring readiness at every milestone.
    • End‑to‑end ownership of a safety case through a full certification…
    • Minimum of Salesforce Developer or Salesforce Administrator certifications.
    • Salesforce Platform Developer 2 certification is a strong plus.
    • Windows 11, macOS, iOS/Android device management Microsoft 365 Administration (including Intune, Windows Defender, Autopilot).
Get email updates for the latest Certification Specialist Medical Devices jobs in Ontario

By creating a job alert, you agree to our Terms . You can change your consent settings at any time by unsubscribing or as detailed in our terms.

Career Resources:

Job Post Details

Hitachi logo

Technical Specialist, Quality Assurance - job post

Hitachi
3.5 out of 5 stars
Toronto, ON
$102,481–$131,594 a year - Full-time
You must create an Indeed account before continuing to the company website to apply

Job details

Pay

  • $102,481–$131,594 a year

Job type

  • Full-time

Shift and schedule

  • Flextime

Location

Toronto, ON

Benefits

Pulled from the full job description

  • Flextime
  • Vision care
  • Dental care
  • Designated paid holidays

Full job description

Location:

Toronto, Ontario, Canada

Job ID:

R1012952

Date Posted:

2026-07-07

Company Name:

Hitachi Rail Canada Inc.

Profession (Job Category):

Quality Management

Job Schedule:

Full time

Remote:

No

About Us

A career at Hitachi Rail will help create a legacy. With operations in every corner of the world, our work goes to the cutting-edge of digital transformation and technology. From the multi-cultural strength of our global organisation to the sustainable and innovative ways we work to bring people together, there’s something for everyone to get stuck into. And that’s where you come in.

Job Description:

The Technical Specialist, Quality Assurance assumes the role of Quality Assurance Manager (QAM) within the Product/Project team organization and has the responsibility of assuring the quality of the overall safety critical CBTC solution and deliverables, while maintaining customer satisfaction. Key tasks include addressing customer concerns, collaborating with teams and suppliers, managing risks, promoting continuous improvement and ensuring “first time right” mindset on every deliverable.

Key Accountabilities

  • Perform compliance assessment for Contractual Quality Assurance requirements.

  • Prepare Bid/Project Quality Plans and bid quality estimates and process adherence across Product/Project teams

  • and within the operational disciplines (engineering- systems, software, hardware, testing, safety engineering and assurance, industry & supply chain, services, deployment, PM, procurement, etc.)

  • Liaise with and guide operational disciplines within Product/Project teams on tailoring while ensuring adherence to standards (ISO 9001, CENELEC EN 50126, EN 50128, EN 50129, AREMA)

  • Plan, execute and document internal audits and site audits

  • Support and participate as needed in internal and external audits (Customer, independent safety assessors, certification audits, supplier audits)

  • Management of audit findings and non-conformances

  • Record and analyze Quality findings from audits and reporting to identify trends or issues to address.

  • Support First Article Inspections as needed

  • Conduct/support Root Cause Analyses and continuous improvement initiatives with the other disciplines

  • Participate and approve bid/project engineering milestones

  • Prepare and communicate quality reporting to various levels of management and disciplines

  • Prepare Quality Management Reports and support teams for safety authorizations

  • Participate in peer review and approval of documentation such as plans and reports

  • Act as a coach to improve quality performance of projects

  • Ensure customer concerns are addressed and managed effectively

  • Manage customer surveys and actions

  • Liaise with the customer’s quality representative during bids and contract execution

Key Requirements

  • B.S Computer Science/Electrical/Mechanical/Computer Engineering or equivalent

  • 10+ years of hands-on experience in Engineering System/Software development or Quality Assurance Specialist or Manager in a technology or manufacturing setting

  • Must have a solid understanding of general QA practices and procedures, Quality Management System

  • Ability to conduct investigations and Root Cause Analysis across multiple disciplines (System, Software,

  • Hardware, PMO....)

  • Required are excellent problem solving, written, verbal and communication skills

  • Technical/Specialized Knowledge: Industry Standards: CENELEC/AREMA/IEEE , ISO 9001, Project/Product Lifecycle and Deployment (System, Software, Hardware)

Preferred Qualifications

  • Hands-on Engineering System/Software development or Quality Assurance in complex System environment with

  • certification constraints (Transportation, Aerospace, Medical Devices, Nuclear, Cybersecurity)

  • Knowledge of Transportation domain / CBTC system is an asset.

  • Generative AI Prompting, Python

  • Experience with CMMI

  • Process Improvement Training or background (Six Sigma Green Belt, DMAIC)

  • Other Safety Critical Industry Standards: DO-178C/ISO 13485

  • Written and spoken French language proficiency is an asset

  • Certifications: American Society of Quality (ASQ) Certification (CQE, CQA...) , ISO 9001 Lead Auditor

Base Salary : $102,481 – $131,594

The Company provides an extensive benefits program for all full-time employees working 24 or more hours per week and their eligible dependents, including the following:

  • Health, Dental and Vision plans - 100% of premiums are company-paid

  • Retirement Savings Plan with a company match

  • Company paid holidays - 3 weeks of vacation

  • Company provided Life and accident Insurance, LTD

  • Worklife programs such as Flextime and a variety of Development and Training opportunities

This posting relates to an existing vacancy.

Our hiring process uses both human and technology‑assisted (AI) tools to support candidate screening and assessment. All results are reviewed by people, and all hiring decisions are made by people .

Thank you for your interest in Hitachi Rail. If your application is of interest, we will be in contact. Please do not hesitate to discover more about us and our latest jobs at https://www.hitachirail.com/careers .

At Hitachi Rail, there is a place for everyone. We welcome and value differences in background, age, gender, sexuality, family status, disability, race, nationality, ethnicity, religion, and world view. It is our commitment to create an inclusive environment - we are proud to be an equal opportunity employer.

We would be delighted if you would be one of our followers at https://www.linkedin.com/company/hitachirail

Let Employers Find YouUpload Your Resume