JT882 - MANUFACTURING ENGINEER II

Quality Consulting Group • Juncos, PR • 1d ago

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:

Execute equipment & test method validations, perform manufacturing procedure changes.

Reviews the work of other specialists; may manage some elements of projects.

Conduct 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 Device

Perform documentation changes processes.

Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.

Ensures processes and procedures are in compliance with regulations.

Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Qualifications:

Bachelor's degree in engineering (Electrical, Mechanical, Industrial preferred).

2+ years of Engineering experience in Medical Device industry

Computer system & Equipment (non-CSV), test method validations

Documentation changes

Availability to work extended hours including weekends, great team work

Process Validation and Computer software validation knowledge.

Equipment Validations Manage Supplier Change Requests

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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