Beschreibung
Quality Engineer, Validation Consultant (m/f)
Reference: -en
Start: 02/19
Duration: 6 MM++
Main tasks:
- Responsible for the integration of Vendors currently controlled within the QMS of an acquired company, EIT, a 3D-Printed Spinal Implant Vendor, onto the DePuy Spine ASL. This position will ensure that current supplier controls within EIT’s QMS are maintained, while working with the vendors to document/improve process controls to ensure seamless integration onto the DePuy ASL.
- This role will provide Quality Leadership for the control of multiple vendors supporting the manufacture of 3D-Printed Spinal Implants, including Instrumentation, Sterilization, Sterile Packaging, Acid Etch, and Laser Marking. Ownership will include Supplier Quality relationships with each vendor.
- Work at select Vendor locations to: Remediate quality documentation, Conduct Process, Capability Studies, Manage the vendor in creation/execution of Validation Studies as required, Develop supplier proficiency in risk assessment such as PFMEA, Manage training and certification of operators and inspectors to CTQs with the suppliers as required, Develop and implement efficient and effective inspection points and control plans at the supplier that will eliminate further inspection at a DePuy Synthes site.
- Conduct on-site quality and process assessments at Vendor’s to approve new suppliers and ongoing assessment of established suppliers.
Main qualifications
- Previous experience in a quality role within a regulated industry
- Experience with Quality Auditing (external)
- Knowledge of FDA, ISO and other specific Quality System requirements specific to Medical Device Design and Manufacturing
- Knowledge of Additive Manufacturing (3D-Printing) processes
- Thorough understanding of quality systems and regulations and business impact of decisions and actions
- Willingness to travel
- Process Excellence – Green/Black belt certification
- Experienced in SPC, Product Validation and ISO 13485
- Medical device/diagnostic industry experience
- Language requirement: English = Business Fluent. German or French is a plus
Main advantages:
- Fascinating, innovative environment in an international atmosphere
- Interesting assignments at renowned national and international companies
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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My contact person:
Sonja Lentz
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