About the role

Quality Engineer overseeing quality improvements and compliance in Manufacturing and R&D departments. Collaborating cross-departmentally to enhance product quality and efficiency.

Responsibilities

Overseeing Quality Improvements across Manufacturing and R&D to ensure product quality and consistency
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.

University degree in Engineering or Science; or relevant work experience
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 working on projects in a regulated environment; medical device development experience is an asset
Experience transferring designs from engineering to manufacturing
Experience operating in a quality environment such as GLP, GMP, GCP, ISO 13485 or equivalent
Valid passport for travel to United States and Europe.