Supplier Quality Engineer (m/f/d)

REFERENCE NUMBER:

561222/1

MY DUTIES:

- Project Goal is to ensure all externally manufactured products meet new EU MDR requirements
- Collaborate with suppliers to obtain details for manufacturing process information, production risk management, process controls, validation and direct part marking - this information will be used to update the product’s technical file to be in compliance with Medical Device Regulations
- Become a working member of the technical file remediation efforts to ensure externally manufactured products meet EU MDR requirements - this includes supporting project deliverables, meeting project timelines, resolving identified supplier issues and executing the overall project related to technical file remediation requirements
- Assess supplier drawings and process information to support project deliverables (Manufacturing Process Information and Controls, Production risk management file, Validation protocols and reports, Direct part marking documentation)
- Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information
- Cross coordinate Workstream activities/interdependencies with other workstream and project teams
- Partner with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Workstream activities
- Support definition and clarification of EU MDR supplier related process requirements
- Support Review and Approval EU MDR Change Projects as applicable
- Support Supplier Quality Functional Impact Assessments as applicable
- Support Review and Approval of supplier Process Validation Protocols and Reports as applicable
- Support the update of supplier related Inspection Criteria as applicable

MY QUALIFICATIONS:

- Bachelor or Master (or equivalent) in engineering or associated technical field
- Experience as Supplier Quality engineer, Supplier Process Validation engineer, Project Engineer, Project Manager or equivalent role within regulated industry
- Understanding supplier management and validation procedures and execution
- Strong background in Medical Device Regulatory Compliance/Regulatory Affairs (working experience in the Medical Device industry)
- Experience in working with suppliers across multiple sites and franchises
- Ability to act as an SME in supplier business processes
- Experience with medical device technical files
- Fluency in English and German

MY BENEFITS:

- A very renowned company
- Central location
- Interesting tasks in a multinational environment

ABOUT HAYS:

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.