Responsibilities:
- Working on the introduction on a new product and/or components
- Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
- Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
- Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
- Adapts machine or equipment design to factory and production conditions.
- May incorporate inspection and test requirements into the production plan.
- 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.
- Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.
Qualifications:
- Bachelor’s degree in Engineering
- 3+ years of relevant experience.
- Process Development and documentation
- Equipment validation
- SOP Development
- Special Build Documentation and Line Support
- Experience in equipment IQ
- Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
- Process Validation Lifecylce ( from process characterization, operational qualification to performance qualification)
- Preferred experience in DOE (with minitab)
- Computer and software validation CSV
- SOP Development
- Change control of Medical Devices
- MES system
- Shift: 1st shift
Skills Required
- Bachelor's degree in Engineering
- 3+ years of relevant experience
- Process development and documentation experience
- Equipment validation experience
- SOP development experience
- Special build documentation and line support experience
- Equipment IQ experience
- OQ and PQ and/or process validation experience
- Process validation lifecycle experience, including process characterization, OQ, and PQ
- Computerized system validation experience
- Medical device change control experience
- MES system experience
- DOE experience using Minitab
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
