At ONWARD we're looking for a Senior Quality Engineer to join our team.

Full-time · Lausanne

About the job

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.

About you

• 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

Apply for the job

Do you want to join our team as our new Senior Quality Engineer? Then we'd love to hear about you!