Medical Device Affiliate QMS Instructor Consultant

Our Client - ELIQUENT Life Sciences - is seeking bilingual Medical Device Affiliate QMS Instructor / Consultants in Costa Rica. The roles are home-based and require the ability to travel to client sites for delivery, or the ability to deliver through virtual technology. We are seeking highly organized individuals who are self-starters, good communicators and are open to flexible work arrangements, seeking variety in the work they do.

Position Description

A Medical Device Affiliate QMS Instructor / Consultant is responsible for planning and leading public training courses, and private courses for major clients related to quality system audits, development, deployment, remediation, and/or regulatory affairs activities such as submissions, clinical study, and post-market surveillance. Instructors with consulting and/or audit skills may also have the opportunity to be involved in consulting and/or audit projects. The role is primarily that of an individual contributor, although teamwork is expected.

Person Description

• Confident personality and competent in getting ideas across to others effectively
• Bilingual - English/Spanish
• Has demonstrated the ability to work in a team environment, especially when operating remotely
• Has a passion for patient safety through effective regulatory and quality activities
• Respects the contribution of all colleagues and facilitates consensus on tough issues
• Demonstrates flexibility in day-to-day working in the team and approach to unique client issues

Basic Qualifications

• Bachelors degree in Engineering, Science, or life sciences-related field
• Evidence of progressively taking more responsibility and leading activities in their field
• Delivery of a significant number of workshops in a public, or private setting

Industry Requirements

• Experience with medical device or in-vitro device manufacturing, interpretation, and application of codes, regulations, and standards, GMP
• Experience with quality systems planning and implementation, design control, and process validation
• Experience with submissions, remediation, clinical evaluation, post-market surveillance, risk management
• Experience with FDA 21 CFR Part 803, FDA 21 CFR 11, & FDA 21CFR Part 820 and/or relevant EU Directives
• Experience with any of MDSAP; ISO 17025:2017; ISO 14971:2019; ISO 27001:2013 a plus

Travel

Ability to travel extensively domestically (50% - 75%). Occasional international travel may be required.