- Manage and execute suppliers' qualification audits and related audits follow up according to audit plan,
- Ensure suppliers' management activities according to standard DM procedure,
- Manage nonconformities from suppliers (audits, incoming, production issues) and CAPA plans defined by suppliers and follow up.
- Contribute on needed changes on ERP / QMS systems (new/update inspection plans, QA items configuration, procedures),
- Define and participate on continuous improvements of our products and processes (lean six sigma, etc.),
- Participate on monitoring CMOs KPIs, data trend analysis and Product Quality Reviews.
- Bachelor's degree in an engineering science (mechanical, electronics) or operational quality,
- 4-6+ years' experience in Design or Manufacturing engineering within the Medical Device industry or similar,
- External Lead Auditor certificate to perform audits according to ISO 13485 and 9001,
- Experienced / trained on ISO 13485 and 9001 standards,
- Experience in non-conformities and CAPA management,
- Proven experience on KPI measurement, quality reports and data trending / analysis,
- Manufacturing and engineering skills - knowledge of manufacturing and production processes, process enhancement (provide guidance on improving process efficiency while maintaining a high level of quality, safety, and reliability),
- Excellent written and verbal in-house and external communication and liaison skills,
- English Fluent, French & German a plus,
- Open to travel – up to 30% (all world).
- Opportunity to work in a fast-growing company active in one of the most promising fields of medicine.
- A dynamic atmosphere in an internationally minded environment.
- Permanent contract with 25 days of paid vacation.
- Benefit from one day to two days per week working remotely to boost flexibility.
- An attractive talent development programs and initiatives empowering employees to enhance their skills and fostering professional development growth.
- Mobility plan, competitive company pension plan, support for gym memberships.
- Regular team building events such as boot camps, skiing and much more.
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Product & Supplier Quality Engineer - Épalinges, Schweiz - Distalmotion SA
Beschreibung
About us
At Distalmotion, we aim to deliver the benefits of robotic surgery to more surgeons, more hospitals, and more patients globally. Our vision is to establish a new standard of care, removing traditional barriers and complexities of robotics to ensure greater access to best-in-class minimally invasive surgery.
We are a diverse, international team, headquartered in Lausanne, Switzerland, with a growing presence and footprint globally. With over 150 members, more than 25 nationalities, speaking over 15 languages, we are all united by the same goal — bringing patients the best in minimally invasive surgical care.
Are you looking for a new fulfilling challenge in a fast-growing medical device company? Join a team engaged in empowering robotic surgery, the new medical revolution.
About Product & Supplier Quality Engineer
Support Product & Supplier Quality department on supplier quality activities namely suppliers' qualification process and product quality activities for Distalmotion manufacturing lines for sterile instruments, Dexter robot system and its accessories.
Tasks:
Supplier Quality:
Product quality:
Requirements:
Benefits:
Distalmotion is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We provide equal employment opportunities to all qualified applicants and employees.
Distalmotion is a medical device company founded and headquartered in Lausanne, Switzerland. It was founded in 2012, as a spin-off from the Robotics Lab of the Swiss Federal Institute of Technology in Lausanne (EPFL). Our objective is to remove the complexity out of robotic surgery in order to fast track its widespread adoption in minimally invasive care. To do so, we want to continue disrupting minimal invasive surgery - but we will only succeed with the right people on our team. Join our team to address critical healthcare needs and improve patients' lives
For further information visit: and follow us on LinkedIn/Twitter: @Distalmotion.
