JT899 - PROCESS ENGINEER I

Quality Consulting Group, LLC; Humacao (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented engineer to join our team in Puerto Rico and the USA. The role focuses on technical and sustaining engineering support in a manufacturing setting with emphasis on validation for medical devices.

You will lead process improvements, collaborate with cross-functional teams, and implement equipment and methods that meet quality standards. Shift availability may be required for first and second shifts.

Qualifications

• Bachelor's degree in the specified engineering fields.
• 3+ years of validation experience.
• Knowledge of validations in a medical devices environment.
• Able to collaborate with cross-functional teams on solutions.
• Strong problem-solving skills and attention to detail are essential.
• Willingness to work first and/or second shift if required.

Responsibilities

• Provides technical and sustaining engineering support in a manufacturing area.
• Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies.
• Integrates equipment and material capabilities to meet process specifications.
• Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
• Interacts with design and development to ensure processes and designs are compatible.
• May develop and conduct statistical analysis to document work.
• Leads development/optimization of new manufacturing concepts and transfer to operations.
• Develops manufacturing processes applicable to SPC and measurement systems.
• Ensures processes comply with regulations.

Skills

Cross-functional collaboration

Problem solving

Attention to detail

Shift flexibility

Education

Bachelor's degree in Mechanical/Biomedical/Industrial/Chemical 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:

• Provides technical and sustaining engineering support in a manufacturing area.
• Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products.
• Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
• Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
• Interacts with product design and development personnel to ensure that processes and designs are compatible.
• May develop and conduct statistical analysis or recommend additions to document work.
• Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations.
• This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.
• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
• Ensures processes and procedures are in compliance with regulations.

Qualifications:

• Bachelor's degreein Mechanical, Biomedical, Industrial or Chemical Engineering
• 3+years in validation experience
• knowledge in validations in a medical devices environment.
• You will collaborate closely with cross-functional teams to develop innovative solutions and improve manufacturing processes.
• Strong problem-solving skills and attention to detail are essential for success in this role.
• Availability to work first and / or second shift (If require) mainly first 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.