Design Controls Consultant (REMOTE) in Framingham, MA at Eliassen Group

Date Posted: 4/13/2021

Job Snapshot

Job Description

EG Life Sciences has a client in the Medical Device Industry looking for a Senior Design Controls Engineer for a REMOTE project. This consultant will be assisting in the development and production of innovative combination products by ensuring quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.

This is a REMOTE consulting assignment that is expected to last 3-6 months. 

Our client is looking for:
  • 8+ years in the Medical Device Industry
  • An Engineering related degree (ie. Biomedical, Software, Electrical or Mechanical)
  • Thorough understanding of Medical Device QMS requirements
  • FDA CFR 21 820 and ISO 13485
  • Expertise in Design Controls, Design Verification, & Validation
  • Expertise in Process Controls, CAPAs and Risk Management
  • Understanding of manufacturing & production process control methodologies
Job ID: 350651

About EG Life Sciences:

Founded in 2010, EG Life Sciences is a national professional services firm that delivers flexible, scalable solutions for Medical Device, Pharmaceutical, and Biotechnology companies. We provide the resources they need to meet the unique challenges of FDA regulations and submissions. Our team is comprised of leaders who are clinical development professionals and veterans of the FDA-regulated healthcare industry with significant technical knowledge and expertise. The practice is also supported by a seasoned technical recruiting and project delivery/support team. This combination enables us to quickly deliver value-driven consulting, interim leadership, technical project management, and time and material and project-based staffing solutions.

Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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