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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:

• Review plant defect reports, customer complaints, failure investigations and audit findings to assess manufacturing related issues that may impact quality and recommend courses of corrective action.

• Conduct manufacturing non conformances investigations, customer complaints, CAPA, failure investigations and audit findings.

• Escalate manufacturing related issues that may impact quality and recommend courses of corrective action.

• Participate in regulatory agencies audits.

• Assist in the investigation of product non conformances and the gathering of information during regulatory inspections and field actions when required

 • Approve or review product investigations reports.

• Perform and report line defects trend analysis, cost of quality, and period quality summaries.

• Participate in new product or technology transfers to assess the impact they may have on the quality and reliability of the product – assist in process validation protocol.

• Follow-upon commitments to FDA and ISO observations for manufacturing related issues and report trends.

• Perform quality system audits to determine compliance to FDA, ISO, and internal quality systems regulations and perform quality system surveys to evaluate the overall quality capability of a prospective or actual supplier or contractor.

• Participate in the development, delivery, and administration of quality training programs including but not limited to GMP.

• Be an active member in facility continuous improvement initiatives to assure continuation of quality measurement, planning, and improvement.

• Provide leadership and guidance to a team of hourly or salary associates, including assigning tasks, setting clear goals, and monitoring performance, as required.

• Facilitate training sessions to ensure team members are equipped with necessary skills and knowledge.

• Develop individual team members through coaching and mentoring.

Qualifications Requirements/Knowledge/Education/Skills:

Bachelor’s degree in Engineering (Industrial, or CQE preferred), advanced degree or process towards advanced degree is a plus. o A minimum of (7) seven years’ experience in manufacturing, quality control, quality assurance, or regulatory compliance, preferably in the medical device or pharmaceutical industr

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.

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