Jt882 - Manufacturing Engineer II
About The Position
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.
Requirements
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
51-100 employees
