Senior Quality System engineer
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.
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.
