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Summary
About the Role
About You
- Bachelor's degree in Life Sciences, Engineering, Quality Assurance, or a related field.
- Minimum of 8 years of experience in quality management within the medical device industry.
- Proven knowledge of regulations and industry standards such as 21 CFR Part 820, ISO 13485, and ISO 14971.
- Strong analytical and problem-solving skills.
- Excellent communication skills, both written and verbal.
- Advanced degrees or certifications such as Certified Quality Engineer (CQE) or Certified Manager of Quality/Organizational Excellence (CMQ/OE).
- In-depth understanding of quality management system processes and risk management techniques.
Benefits
- Flexible employment and benefit options.
- Collaborative culture and welcoming team.
ECI (Enhanced Compliance Inc.) stands as a beacon of excellence in the life sciences consulting arena. With a dedicated team of industry professionals, ECI boasts a proven track record in full product lifecycle consulting for medical devices, pharmaceutical, biotech, and related industries. Our global consultants, with an average of 15 years of experience, provide top-tier quality, regulatory, and engineering solutions which are designed to cater to the unique needs of the dynamic life sciences market. Our team consists of highly skilled and specialized consultants with proven industry ability in FDA and international regulations, quality assurance and management, mergers and acquisitions due diligence, research and development support, regulatory affairs, post-market activities, technical services, manufacturing processes, product engineering, remediation, and project management. ECI's headquarters is in Marlborough, Massachusetts. We also have an operating office in Alajuela, Costa Rica, including a state-of-the-art packaging testing laboratory.