189624 - QA Design Compliance Engineer
Up to $75.00 DOE
9 mos
Chipton-Ross is seeking a QA Design Compliance Engineer for an opening in Chelmsford, MA.

In this key role, you will be a core team member on New Product Development teams, taking projects from Concept to full production and implement necessary controls to ensure successful launch. You will partner with Product Development Engineering teams located at multiple domestic and international sites to ensure success of new product launches and changes to existing products.

Develop new product quality control plans across multiple product lines while providing direction and consultation for implementation of quality process control plans to Product Design Engineers, Process Design Engineers, Quality Engineers and Supplier Engineers. Act as the lead Quality Expert as member of New Product Development Team(s) to assure that all quality deliverables are completed on time. Train and Coach others in APQP techniques and in the use of scientific approaches including statistical tools. Audit New Product Development phase gate deliverables for regulatory and procedural compliance. Identify and drive execution on opportunities for improvement of new product launches based on historical like products

Knowledge of quality continual process improvement techniques in a Lean manufacturing environment and in statistical waste reduction techniques. Proficient in process auditing with significant competency in analyzing. Trouble shooting and resolving complex quality situations. Solid Technical Experience in driving quality improvement projects both internally and with suppliers. Knowledgeable in advanced data collection, measuring, analysis, improvement and control. Strong knowledge of manufacturing processes (assembly, weld, metal forming, paint, electrical assembly) and quality control methodologies and documentation. Proficient in use of Microsoft Office Suite. Working experience with the FDA Quality System Regulation (21CFR820), ISO 9000, ISO 13485 quality standards. Knowledgeable of Advanced Product Quality Planning techniques and tools. Experience in medical device industry and products a plus. Manufacturing or biomedical assessment activities strongly preferred. Strong verbal and written communication skills. ASQ Quality Engineer Certification desirable

Accredited BS degree required.

1st Shift

Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Zachary Fasano
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x252 or (800) 927-9318 x252

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.