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:
- Engineer will help with the Packaging Excellence (PEx) initiative. This initiative was generated to upgrade our sealers with Advanced Controls to have better control of process parameters. Subsequently the equipment needs to be validated for our packaging operations
- Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development.
- Under the direction of the Engineer Section Head, provides technical direction to department engineers.
- Plans and coordinates larger scale engineering projects or several medium or small projects while acting as a technical specialist for a specific section. Maintains a thorough knowledge of new developments and technology.
- Monitors projects and recommends changes to improve operating efficiency.
Qualifications:
- Bachelor Degree in Engineering.
- Four (4) year of previous experience in Medical Device or Pharmaceutical Industry.
- Experience in Equipment validation, FDA Compliance and Statistical Analysis
- Knowledge of Master Validation Plan (MVP), Defining Document (DD), Installation Qualification (IQ), Measurement System Analysis (MSA), Operational Qualification (OQ), Performance Qualification (PQ), Update Documentation (SOP, PFMEA, Process Map) and Packaging Excellence (PEx) form
- Available for 1st shift
Top Skills
What We Do
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 matter
