Quality Engineer

Randstad is a leading global staffing and recruitment company, offering a wide range of solutions in the HR services space. We take the lead in shaping the world of work, by matching candidates with companies that will help them reach their full potential, and matching clients with people who will work to successfully develop their business.

A leader in pharmaceutical manufacturing is currently seeking a Quality Engineer in the Irwindale, CA area. The Quality Engineer would drive quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of the product. This is a 8 month CONTRACT position. No per diem is provided.

* Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle, developing and establish effective quality control and associated risk management plans, and writing, reviewing and/or approving process and product validation protocols and reports, equipment qualifications, engineering change orders. * Using statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE), directing Failure Mode and Effects Analysis activities for both Design and Process FMEA’s, providing all planning necessary to ensure effective product acceptance. This includes, but is not limited to, part qualifications, specification development, and sampling plans, and supporting vendor audits as technical lead as needed and support Supplier Quality as Quality Operations/Product Quality representative as appropriate. * Participating in MRB review of nonconforming product; recommend disposition and corrective action, initiating and investigating Corrective and Preventative Actions (CAPA) as appropriate, and assisting in developing submissions for process changes, inspection changes, and new processes/devices as necessary. * Participating in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes, and assessing the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by testing is advisable.

* Bachelor's degree and 2+ years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required. Master's degree preferred. * American Society for Quality (ASQ) certification, Six Sigma experience, knowledge of Process Excellence tools, GD&T (Geometric Dimensioning and Tolerancing), and experience with FDA, ISO 13485, CMDCAS, PMDA are desirable. * Thorough knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices and leading edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies are desirable. * Must be competent in MS Office and have good verbal and written communication skills.