Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities:

• 
  Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards .
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Act as Voice of Quality function on deliverables needed to remediate products to EUMDR and provide guidance to other cross functional team members from Quality function point of view
• Interpret guidance documents and ISO Standards and apply them to EUMDR remediation.
• Broad understanding of how medical devices are approved in European Union such as interactions with Notified Body’s, Quality system requirements.
• Existing familiarity or ability to quickly come up to speed with other changing medical device regulations in the Europe region.

Qualifications Requirements/Knowledge/Education/Skills:

• Requires a University Degree in Engineering with a minimum of 3 years of relevant experience.
• Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience specially in Packaging, Validations and Regulations as EUMDR and ISO Standards .
• Bilingual (Spanish, English)

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

JxCBtmLlvt