Job Information
Integra LifeSciences QS Senior Engineer in CH, Switzerland
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
Responsibilities:
QMS:
Participate to procedure creation and update
Participate to document control activities
Ensures GMP, GDP rules are known, understood and respected in the site
Ensure Quality System support in all departments
Escalates quality issues and make 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 trainer for the site
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 in a timely manner
AUDIT:
Act as Audit process trainer
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:
Act as QP process trainer
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, Quality Reviews
Ensure KPI and Quality Reviews are handled in compliance with internal procedures as well as applicable standards
Participates and supports the KPI, Quality Review process
Qualification :
A minimum of a Master’s Degree is required, preferable in Engineering, a Life Science, pharmaceutical or a related technical discipline.
Minimum Experience of 5 years working in a Medical Device, or pharmaceutical or technical manufacturing environment is preferred.
Fluent in French and English
Knowledge of Medical device standards and regulations such as ISO13485, EUMDR 2017/745, 21 CFR part 820
Good communication, organizational, negotiation and interpersonal skills
Good analytical problem-solving skills.
Use of Agile, Oracle, EtQ, TWD, ICDH
Use of Microsoft office tools
Good knowledge of statistical techniques
Integra LifeSciences
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