Responsibilities:
- Provide day-to-day engineering support to production lines to ensure consistent and efficient manufacturing operations.
- Troubleshoot process deviations, equipment issues, and yield losses to quickly restore production.
- Monitor manufacturing performance metrics and identify trends affecting quality, scrap, cycle time, and throughput.
- Support production teams during shifts to resolve technical issues and minimize downtime
- Identify and implement continuous improvement initiatives to enhance process capability, productivity, and cost efficiency.
- Interacts with product design and development teams to promote and implement improvements.
- Lead or support Lean Manufacturing and Six Sigma initiatives.
- Analyze process data to identify root causes of variation and implement corrective and preventive actions.
- Manage and document product and equipment investigations.
- Bachelor’s degree required; B.S. in Mechanical or Electrical Engineering preferred
- Minimum 3 years medical device manufacturing experience.
- Process controls, PLC, HMI, vision systems, pneumatics, lasers, robotics, servos, statistical techniques.
- Works irregular hours, shifts, as needed
Skills Required
- Bachelor's degree
- B.S. in Mechanical or Electrical Engineering
- Minimum 3 years medical device manufacturing experience
- Process controls
- PLC
- HMI
- Vision systems
- Pneumatics
- Lasers
- Robotics
- Servos
- Statistical techniques
- Ability to lead or support Lean Manufacturing and Six Sigma initiatives
- Willingness to work irregular hours and shifts as needed
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
