Affiliate - Software Quality Trainer / Consultant (Medical Devices)

Location: Remote - USA, Canada, UK, Ireland

Hiring Company: Oriel STAT A MATRIX (Website)

Founded in 1968, Oriel STAT A MATRIX is now a business unit of ELIQUENT Life Sciences, a leading global organization providing consulting and training services to the Regulatory Affairs and Quality Assurance functions within the Life Science industry. We are proud of our focus on client outcomes: we achieve superior client results because we select from a pool of highly skilled, specialized, commercially minded Quality System and Regulatory Affairs employees and a set of Affiliate consultants with exceptional skills in specific areas. Together, our team can execute best-in-class advisory, audit, consulting and training services in the medical/in-vitro device market. We are looking for individuals who possess a level of skills, attributes and talents commensurate with our brand.

Our Affiliate Software Quality Trainer / Consultant roles are for independent contractors. They are home based and require the ability to travel to client sites for delivery, or the ability to deliver through virtual technology. We therefore seek 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

The Affiliate Software Quality Trainer / Consultant is responsible for planning and delivering Life Science software training, audit and consulting engagements related to quality/regulatory affairs infrastructure, appropriate to the level of risk in a target product. Post holders will also be expected to contribute to the development of training and consulting intellectual property.

Person Description

• Confident personality and competent in getting ideas across to others effectively
• Demonstrates ability to work in a team environment, especially when operating remotely
• Passion for patient safety through effective quality assurance and audit activities
• Respects 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
• Ability to assimilate diverse data, think critically and solve problems

Basic Qualifications

• Bachelors degree in Engineering, Science, or life sciences related field, masters preferred.
• Evidence of progressively taking more responsibility and leading activities in management or as a high-level individual contributor
• A minimum of seven years leading medical device software related projects
• Leading at least 20 audit engagements under ISO13485:2016, MDSAP or EU-MDR
• Outstanding ability to think critically, solve problems, and learn new concepts and activities

Industry Requirements

• Experience with medical device manufacturing, interpretation and application of codes, regulations, and standards
• Experience with quality systems planning and implementation, design control and process validation
• Experience with software development lifecycles and cybersecurity activities
• Experience with FDA 21 CFR Part 803, FDA 21 CFR 11, & FDA 21 CFR Part 820 and/or relevant EU Regulations
• Experience with ISO 14971; ISO 27000; ISO 80001/2; IEC62304 SDLC

Travel

Ability to travel extensively domestically (30% - 50%). Occasional international travel may be required.