Development Quality Engineer
Experis, a ManpowerGroup company has an exciting contract opportunity for Test Technician. This position is a 8+ months (possible extension) for one of our key clients, a global Pharmaceutical /Medical device company that is engaged in the discovery, development and manufacturer of healthcare products.
Job Title: Development Quality Engineer
Location: 5050 Nathan Lane N. Plymouth, Minnesota - 55442
Duration: 8+ months (possible extension)
Manager notes:
Key responsibilities :
- Lead high visibility product development quality engineering initiatives. Emphasis on design control file gap assessments and remediation activity for EU MDR products. This is an individual contributor role on an engineering team.
Typical day:
- Perform EU MDR gap assessments for assigned products. Analyze and evaluate product/customer risks (UFMEA, DFMEA and Hazard Analysis). Review CAPAs, deviations and non-conformance reports to understand issues and judge appropriateness of outcomes.
- Partner with R&D to create/execute new protocols and reports (test methods, design verification, design validation, etc). Populate GSPR documentation (General Safety and Performance Requirements). Collaborate with other functional groups as necessary to ensure timely and accurate EU product submissions.
Basic knowledge
- Understand design control procedures and development processes. Be able to identify/create technical documentation to show evidence of compliance. Navigate Design History Files and supporting documentation evidence.
Required experience
- Demonstrated ability to author protocols, reports and technical justifications (TMV/DV/Design Validation/OQ/PQ/PPQ).
Products Supported
- Permanently implanted heart repair and treatment devices. Occluders, delivery devices, surgical & transcatheter heart valve products plus accessories.
- candidates need to be prepared to provide detailed examples of the type of work they performed. process validation knowledge and experience is a requirement
Thanks & Regards,
Mridul Singh
Talent Acquisition Specialist
Experis CORE+
Phone: Ext: 7192
Text:
Email:
Linkedin:
100 Manpower Place, Milwaukee WI 53212
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