Senior Quality Engineer
At ONWARD we're looking for a Senior Quality Engineer to join our team.
Full-time · Lausanne
Senior Quality Engineer
The Senior Quality Engineer ensures adherence to applicable Quality Standards and Regulations and provides support on design transfer, production and post-production activities of ONWARD medical devices in compliance with our ISO13485 based QMS.
Responsibilities
Support our manufacturing engineering department on topics such as design transfer activities, manufacturing process validation, risk management and monitoring of manufacturing activities.
Support our development department by providing necessary inputs to achieve products design for manufacturing.
Support our supplier control and monitoring teams as necessary.
Support change control process related to change of products design or manufacturing.
Lead non-conforming product investigations and related topics like execution of CAPA and audit findings.
Release of products for commercial use or clinical studies.
Manage structural improvements in the QMS.
Bachelor’s or Master’s degree in life sciences or engineering.
Multiple years’ relevant industry experience in medical devices (preferably active implantable devices) and knowledge of ISO13485, EU MDR, FDA Regulations.
Experience with test method validations and process validations.
Experience in investigation, root cause analysis, corrective and preventive actions.
Experience or strong affinity with supplier control processes and/or risk management.
Experience in writing and maintaining Quality Management System procedures, Quality Assurance & control methodologies.
Experience with internal and external audits.
Analytical, methodical and process-oriented thinker, yet with a pragmatic and results driven mindset, not hindering the speed of Development.
Strong interpersonal skills, able to influence others without authority.
An energetic, hands-on individual who enjoys working in an international, cross-functional environment within a young and growing company.
Excellent English language proficiency, proficiency in French language is highly appreciated.
Represents the ONWARD CODE (values): Empowered, Committed, Pragmatic, Innovative, Open, Trusting and Collaborative
Do you want to join our team as our new Senior Quality Engineer? Then we'd love to hear about you!