Quality Engineer- Supplier Manager
vor 2 Monaten
SPINEART is a privately held medical device company based in Geneva, Switzerland, focused on simplifying the surgical act by designing, developing, and promoting safe and efficient solutions to spine surgeons, operating room teams, and patients.
Selling in over 60 countries, Spineart is a pioneer in its field, having introduced unique technologies in the fields of Minimally Invasive Surgery, Motion Preservation, Fusion, Biologics and Fracture Treatment.
Spineart markets a complete portfolio combining traceable barcoded sterile packed implants with compact instrument sets, thus proudly promoting greater safety, cost-efficiency, and compliance at the hospital.
Our success also depends on our team’s value. The human being is at the centre of our concerns. We pay special attention to our recruitment to make Spineart a great place to work.
For us, soft skills are as important as hard skills. What we expect from our employees is nothing short of real team spirit, mutual assistance, and self-transcendence.
Our philosophy: Quality, Innovation, Simplicity
Our values: Respect, Integrity, Solution oriented
Are you a highly skilled Engineer who is dreaming of a job with a real impact on patients ’lives?
Do you want to work for an innovative specialist spinal implant company and play a crucial role in ensuring efficiency of our manufacturing processes?
If yes, come to join our Process Validation team as
Quality Engineer- Supplier Manager
As Supplier Manager you will develop, and establish supplier related quality processes, and monitor quality supplier KPI’s.
Your main responsibilities will be:
- Participating as an active member in the sourcing and initial supplier evaluation
- Initiating and updating Supplier Quality agreement
- Creating, following and accountabling to the supplier audit planning performance
- Performing suppliers’ audits,
- Monitoring and driving supplier corrective action process and continuous improvement activities that directly impact supplier performance
- Performing, following supplier change control, non-conformance management/resolution (SCAR)
- Qualifying and validating the supplier processes (from machining, post process until packaging processes)
- Participating to the double sourcing plan activities
- Measuring and communicating supplier performance on key metrics and the corresponding continuous improvement plans.
- Helping the supplier in effective root cause analysis and continuous improvement activities.
- Maintaining, supporting compliance of and improve processes, including procedural and electronic systems
Your profile:
- Minimum 8 years of recent experience in Manufacturing /Quality Engineering, ideally in Medical Device industry
- Knowledge of ISO 13485 and FDA regulations.
- Experience with statistical methods preferred
- Experience within medical device industry or spine surgery would be an advantage
- Solid understanding of regulatory requirements, as ISO 13485
- Higher qualification in Engineering, preferably in Mechanical
- Strong communication and negociating Skills, with the ability to effectively convey technical information to diverse audiences
- Good writing skills (structured documentation such as protocols and reports)
- Able to work in English, french equivalent to mother tongue
- Driving Licence
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