Quality Risk Manager

vor 3 Monaten

PlanlesOuates, Schweiz Spineart SA Vollzeit

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 highly skilled in Medical Device quality?

Do you want to work for an innovative specialist spinal implant company and play a crucial role in ensuring efficiency of our Quality processes?

**If yes, come to join our RAQS team as Quality Risk Manager**

Together we can shape the future of the healthcare.

As Quality Risk Management Process owner, you will ensure, that the applicable rules defined in the ISO14971 and QMS are fully always respected.

**Your main responsibilities will be**:

- Optimizing constantly the quality related risk management process by considering all internal inputs and external inputs coming from regulatory reviews, audits and others,
- Ensuring that all applicable regulations and standards are implemented in an optimized manner in our QMS (in particular the ISO14971), known by employees and constantly respected,
- Organizing training and relevant support to concerned staffs to ensure proper use of risk management in all applicable area, like product and process development and change,
- Defining tools to simplify and automate the process ,
- Implementing a periodic follow-up system with concerned parts to review, improving and updating constantly all FMEAS (D&U FMEAs, Process FMEAs, System FMEAs and others),
- Implementing pertinent KPIs and periodic review boards to ensure that the process is well managed,
- Building a yearly assessment for the management review by using KPIs and all out-puts data to demonstrate the process efficiency,
- Reporting deviations to the board,
- Participating to any other activities the service oversees as NC/CAPAs, QMS improvement, training, internal and external audits.

**Your profile**:

- A minimum of 5 years’ experience in quality risk management is required, in usability, design and manufacturing of Medical Devices,
- The ISO 14971 standard must be fully mastered,
- Good knowledge in ISO 13485, MDR 2027/745 is a plus,
- Knowledge in usability (IEC 62366) and clinical evaluation is also a plus,
- Facilitator and good communicator: the person will interact with all departments,
- Good writing skills,
- Able to work in English, french equivalent to mother tongue

**Job Types**: 100%, Permanent

Schedule:

- Monday to Friday

Work Location: In person

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