We are currently seeking a Senior Quality System engineer for one of our clients in Canton of Neuchatel.

If you are looking to work in a dynamic and very friendly working environment and in the medical devices sector then this is for you.

This is an open ended temporary contract.

Please note this vacancy requires fluency in French.

Your responsibilities:

QMS:

• Participate to procedure creation and update

• Ensures GMP, GDP rules are known, understood and respected in the site

• Ensure Quality System support to all departments

• Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a

• compliant manner.

• Manages or participates to quality projects

CAPA:

• Act as CAPA Process Owner

• Ensure CAPAs are managed in compliance with internal procedures as well as applicable standards

• Follow up CAPA process and ensure CAPA are handled and documented adequately

• Ensure Audit process support to all departments

AUDIT:

• Participates and supports internal and third party audits / inspections

• Perform internal audits

• Ensure internal Audit planning is implemented and follow up

• Ensure Audit process support to all departments

QUALITY PLAN:

• Ensure QP are managed in compliance with internal procedures as well as applicable standards

• Participates and supports the QP process

• Ensure QP process is implemented and follow up

• KPI, QMR

• Ensure KPI and QMR are handled in compliance with internal procedures as well as applicable

• standards

• Participates and supports the KPI, QMR process

• Ensure QP process is implemented and follow up

Your profile:

• A minimum of a Bachelor Degree is required, preferable in Engineering, a Life Science or a related technical discipline.

• Minimum Experience of 5 years working in a Medical Device manufacturing environment is preferred.

• Fluent in French and English

• Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, EUMDR 2017/47, 21 CFR part 820

• Good communication, organizational, negotiation and interpersonal skills

• Good analytical problem-solving skills.

• Use of Agile, Oracle, EtQ, TWD

• Use of Microsoft office tools

• Good knowledge of statistical techniques

Those lines sound interesting ? We are looking forward to receiving your application.