JT587 - MANUFACTURING ENGINEER II

Quality Consulting Group, LLC; Villalba (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented engineer to design manufacturing processes in Puerto Rico and USA. Responsibilities include developing manufacturing layouts, supervising equipment performance, and managing validation processes for tools and equipment throughout production.

The ideal candidate will hold a Bachelor's degree in Engineering and possess over 3 years of relevant experience. This role offers opportunities in a dynamic and world-class manufacturing environment.

Qualifications

• 3+ years of relevant experience in manufacturing processes and documentation.
• Proven ability in process validation and equipment validation.
• Experience managing SOP development and special build documentation.

Responsibilities

• Design manufacturing processes and production layouts.
• Inspects performance of machinery and initiates corrective actions.
• Adapts designs to ensure efficiency in production.

Skills

Process Development and documentation

Equipment validation

SOP Development

Experience in equipment IQ

Experience in OQ and PQ

Computer and software validation CSV

Change control of Medical Devices

Experience in injection molding processes

Education

Bachelor’s degree in Engineering

Job description

QUALITY CONSULTING GROUP, a leader inthe 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

• 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 Lifecycle ( from process characterization, operational qualification to performance qualification)
• SOP Development | Special Build Documentation and Line Support
• Computer and software validation CSV
• Change control of Medical Devices
• MES system
• Experience in injection molding processes
• Shift: 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.