Senior Quality Engineer

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Senior Quality Engineer

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!