MANUFACTURING ENGINEER II

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:

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.

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.

Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

Ensures processes and procedures are in compliance with regulations.

Qualifications:

Bachelor degree in Engineering

Four (4) years of relevant experience.

Change control of Medical Devices

Equipment Commissioning / Qualification

Process Validation

Computer System Validation (CSV)

Manufacturing, Packaging and Laboratory Equipment

Technical experience (Trouble shooting) or any similar experience or background

Quality / Process Control / Assurance of Medical Devices

Availability for 1st shift