JT882 - MANUFACTURING ENGINEER II
TEMPORARY•Namora
About this role
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:
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.
- 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.
What you'll do
- The role involves executing equipment and test method validations, performing manufacturing procedure changes, and reviewing the work of other specialists while potentially managing project elements. Responsibilities also include ensuring processes comply with regulations and investigating machinery deficiencies to maintain product quality.
About Quality Consulting Group
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools.
Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matters.
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Frequently Asked Questions
What does a JT882 - MANUFACTURING ENGINEER II do at Quality Consulting Group?
As a JT882 - MANUFACTURING ENGINEER II at Quality Consulting Group, you will: the role involves executing equipment and test method validations, performing manufacturing procedure changes, and reviewing the work of other specialists while potentially managing project elements. Responsibilities also include ensuring processes comply with regulations and investigating machinery deficiencies to maintain product quality..
Is the JT882 - MANUFACTURING ENGINEER II position at Quality Consulting Group remote?
The JT882 - MANUFACTURING ENGINEER II position at Quality Consulting Group is based in Namora, Cajamarca, Peru. Contact the company through Clera for specific work arrangement details.
How do I apply for the JT882 - MANUFACTURING ENGINEER II position at Quality Consulting Group?
You can apply for the JT882 - MANUFACTURING ENGINEER II position at Quality Consulting Groupdirectly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process.