Medical Device Lead Auditor
Vision Achievement
- Ahmedabad, Gujarat
- Contract
- Full-time
- Confident, with gravitas, and competent in getting ideas across to others effectively
- Demonstrated ability to work in a team environment, especially when operating remotely
- Passion for patient safety through effective regulatory and quality activities
- Respect for the contribution of all colleagues and facilitates consensus on tough issues
- Demonstrates flexibility in day-to-day working in the team and in approach to unique client issues
- Established as an independent contractor or willing to be an employee-contractor
- Bachelors degree in Engineering, Science, or life sciences related field
- Evidence of progressively taking more responsibility and leading activities in their field
- Leading substantial audits under ISO13485:2016; MDSAP; EU-MDR with the relevant certification
- Interpretation and application of codes, regulations, and standards in the medical device industry, including GMP
- Experience with medical device or in-vitro device manufacturing
- Experience with QMS: quality systems planning and implementation
- Experience with design control and process validation program development and implementation
- Experience with FDA 21 CFR Part 803, FDA 21 CFR 11, & FDA 21CFR Part 820 and/or relevant EU Directives
- Experience with any of ISO 17025:2017; ISO 14971:2019; ISO 27001:2013 a plus
- A minimum of 8 years of real-world, practical medical device RA/QA experience
- Demonstrable success and career progression
- An understanding of industry trends and current/proposed regulations
- A business-centric, practical approach to RA/QA
- Effective communication skills both spoken and written
- A desire for mutual success
- Be looking to work between 60 and 120 days per year alongside us
- Be free to travel to client sites
- Have independent consulting experience (internal consulting experience may work too)
- Be seeking affiliation with a firm that has high expectations of itself and its Consultant team