Quality Engineer

Profound Medical•Mississauga, ON

99d•$90,000 - $100,000

About The Position

The Quality Engineer is responsible for overseeing Quality Improvements across Manufacturing and R&D to ensure product quality and consistency, improve efficiency, and drive value throughout the business. Quality Engineer helps to identify areas of improvement and ensure compliance to the Profound QMS, relevant regulations and standards.

Requirements

5+ years of experience working in a regulated industry (medical, automotive, aerospace, etc.)
Experience working in a clean room.
Proven examples of fixture/tool implementation projects which deliver meaningful results to the business.
Experience transferring designs from engineering to manufacturing
Experience operating in a quality environment such as GLP, GMP, GCP, ISO 13485 or equivalent
Able to work well in teams and independently
Detail-oriented; highly motivated; patient and diligent
Excellent problem-solving skills
Clear, concise and thorough documentation
Excellent verbal and written communication skills
Valid passport for travel to United States and Europe.
University degree in Engineering or Science; or relevant work experience

Nice To Haves

P. Eng is an asset
Experience working on projects in a regulated environment; medical device development experience is an asset.

Responsibilities

Contribute to a positive work culture and foster a high-performance team environment.
Collaborate with stakeholders across departments to identify areas of improvement and implement quality improvements.
Investigate Complaints, Returned products & Non- Conformities
Improve In-Process and Incoming Inspection testing
Work with the Manufacturing & Operations teams to improve the Capital Equipment and Disposables lines.
Identify opportunities for tools, fixtures & process improvements.
Work with stakeholders to create and deploy fixtures & tooling.
Understand current QMS processes and implement procedure improvements to expedite projects and improve compliance.
Manage product requirements and ensure traceability.
Participate in risk management activities, including the identification and mitigation of potential quality risks.
Ensure processes are set up to encourage adherence to QMS.
Travel as required to support business activities.
Other duties as assigned.