Quality Engineer III

Duration: 11+ Months (40hrs/weeks)

• Lead Quality Engineer for EUMDR Class II & III Compliance Project
• Work in a cross-functional team to assess Supplier Validations and general documentation for compliance to EUMDR requirements and perform required remediation activities.
• Work with supplier base to identify gaps to EUMDR requirements, specifically related to Process Validation
• Prepare Progress Reports and Metrics for review by Sr. Management
• Provide guidance to Junior Supplier Quality Engineers within the bounds of the EUMDR compliance project

QUALIFICATIONS

• Minium 3+ years of demonstrated ability to lead Process Validation activities with suppliers to prove compliance to EU MDR requirements.
• Strong knowledge of EUMDR regulations highly preferred.
• Bachelor’s degree in a scientific discipline, preferably engineering, is required.
• 5+ years experience in a highly regulated industry (Medical Device strongly preferred)
• Working knowledge of Medical Device Regulations and International Standards such as European Good Manufacturing Practices including Directive 93/42/EEC, as amended, and proven experience with EU Medical Device Regulation 2017/745 and US FDA 21 CFR 820, ISO 13485:2016 required
• Strong Quality and Process Validation Skills (IQ, OQ, PQ, PVE) and experience essential to success in this role
• Experience managing complex projects

Shift:

1st Shift