Manufacturing Engineer II — Process Development & Validation

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

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.