JT886 - QUALITY SYSTEMS SPECIALIST

Juncos, Puerto Rico

Temporary

Medical Device

Mid Level

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:

Supports equipment and test method validation and supporting documentation as author or quality reviewer.
Supports process documentation changes as author or quality reviewer.
Provides guidance and expertise to the team regarding quality and compliance procedures.
Provides oversight for the development and maintenance of quality 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.
Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.

Qualifications:

Bachelor's degree in Engineering
2 years of relevant experience with Quality systems
Test Method Validation Analysis
Change control of Medical Devices
Equipment Commissioning / Qualification
Process Validation
Computer System Validation (CSV)
Manufacturing, Packaging and Laboratory Equipment
Technical experience (Trouble shooting) or any similar experience or background
Quality / Process Control / Assurance of Medical Devices
Process Validation and Computer software validation knowledge.
Equipment Validations Manage Supplier Change Requests
Availability for 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.

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