Job Description

Job Overview

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities

Provides

oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.

Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.

Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.

Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Coordinates legal requests in support of government investigations or litigations.

Ensures the quality assurance programs and policies are maintained and modified regularly.

Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

Qualifications

Bachelor's degree in

Science or Engineering

8+ years of related experience

Previous experience on

Quality Systems & CAPA, Change Control and Validations

Knowledgeable on Medical Device Regulatory Requirements

Previous experience with

Quality & Regulatory Audit activities

Shift: 1st shift
Quality Consulting Group, LLC 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.

Work Location: In person