QUALITY CONSULTING GROUP, a leader in the 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 degree in Engineering (Mechanical, Electrical, or Chemical preferred)
- Hands-on experience managing process, performing troubleshooting and implementation of projects.
- Candidates should have specific technical expertise in one or more of the following areas: pneumatics, laser, welding, ultrasonic joining, sensors and control systems, robotics, servo systems, sealing and packaging, vision systems, bonding processes, cleaning processes and injection molding.
- Knowledgeable on basic Process Controls (software, electrical, and mechanical) requirements typical of an automated process, Including, PLC, HMI, vision systems, and motion controls.
- Minimum of 5 years of experience in Validation protocols and reports such as: Equipment IQ, Computer System Validations, Process Characterizations, Process OQ/PQ
- Knowledge in Medical Devices regulations
- Onsite, Full time
- Availability to work 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.
