SRG is looking for a DHF Remediation Quality Engineer to join our client's Medical Device manufacturing team!

Location Requirements: Fully Remote! Hours are 8-5 or 9-6 EST

Duration: 12+ months - long term contract!

Required Skills:

• Education: Bachelor's degree in Engineering or Natural Sciences or Mathematics
• Experience:
  • At least five years in medical device industry supporting mid-sized to large, non-OEM companies (1,000 or more employees), with three of these years in on-market product support, involving a minimum of two years in Design History File Remediation
  • NEED Design History File Remediation for on market products
  • General understanding of bidirectional traceability and decomposition of user requirements to manufacturing requirements
  • General Risk Management document support, including authoring FMEAs (requirement focused on design FMEAs and application FMEAs not process FMEAs) and Hazard Analyses

Desired Skills:

• Master's degree in Engineering or Natural Sciences or Mathematics
• Five years of Design History File remediation, including design and development plans, trace matrix development, and design verification
• Independent authoring of all Risk Management File elements except process FMEAs
• Knowledge of QMSR and general body of Harmonized Standards
• Exposure to EU MDR remediation

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.