Title: Medical Device QMS or RA/QA Trainer

To apply, email resume and cover letter to hr@orielstat.com. Please put “TRNG” in the subject line.

Founded in 1968, Oriel STAT A MATRIX is 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 market. We are looking for individuals who possess a level of skills, attributes, and talents commensurate with our brand.

Our full-time roles are home-based and require the ability to travel to client sites for delivery. 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 Medical Device Trainer is responsible for planning and leading public training courses, private courses for major clients related to establishing and maintaining an appropriate quality assurance system for medical devices. Trainers with consulting or audit skills may also have the opportunity to be involved in projects related to QMS and Audit topics.

This role is an individual contributor position, with a significant amount of team working involved. Preferred will be applicants who have practical knowledge of MDSAP and/or EU-MDR/EU Directive activities AND a minimum of 8 years of recent medical device industry experience. 

Basic Qualifications
  • Bachelor’s degree in Engineering, Science, or healthcare-related field
  • A minimum of 8 years of experience in a relevant Life Science field
  • At least five years delivering training workshops in a public, or private setting

Industry Requirements
  • Interpretation and application of codes, regulations, and standards in the medical device industry
  • Quality systems planning and implementation
  • FDA regulatory compliance, including product submissions
  • MDSAP and/pr EU-MDR experience; CE Mark certification
  • QMS auditing and corrective action plans
  • Design control and process validation program development and implementation
  • Supplier management; Risk management
  • Complaint handling; 483 and Warning Letter responses
Travel
Ability to travel up to 80% of the time domestically. Occasional international travel may be required.

Does this sound like you?  If so, we welcome your application.

To apply, email your resume and a cover letter to hr@orielstat.com. Please place Job Code: “TRNG” in the subject line.

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Oriel STAT A MATRIX is an Equal Opportunity Employer.