JT259 - 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 individual for a manufacturing engineering role in Puerto Rico. This position involves designing manufacturing processes, collaborating on new products, and ensuring quality standards are met.

Qualifications include a Bachelor’s degree in Engineering and 3+ years of relevant experience. Ideal candidates will have expertise in equipment validation, process development, and statistical process control.

Qualifications

• 3+ years of relevant experience in manufacturing or engineering.
• Strong understanding of equipment validation and documentation processes.
• Experience in process validation lifecycle from characterization to performance qualification.

Responsibilities

• Work on the introduction of a new product and/or components.
• Design manufacturing processes and procedures for various equipment.
• Develop manufacturing processes applicable to statistical process control.

Skills

Process Development and documentation

Equipment validation

SOP Development

Special Build Documentation and Line Support

Experience in equipment IQ

Experience in OQ (Operational Qualification)

Experience in PQ (Performance Qualification)

Computer and software validation CSV

Change control of Medical Devices

MES system

Education

Bachelor’s degree in Engineering

Tools

Minitab

Job description

Overview

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic individual 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

• 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

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.