Six Sigma Medical Device $60,000 jobs

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.

Toronto, Ontario, Canada (Hybrid)

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

Total Compensation Range (Base Salary + Annual Incentive plan) : $120,566 - $154,817

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 contribution and a match, and without vesting period

• Company paid holidays - 3 weeks of vacation, Holiday closure, personal emergency leave days and sick days

• Maternity/Parental/Adoption top up pay

• Annual Incentive plan

• Company provided Life Insurance, STD and Employee Assistance Plan

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.

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