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PDS Tech Inc QA Design Compliance Engineer in Chelmsford, Massachusetts

PDS Tech is seeking candidates for a QA Design Compliance Engineer position in Chelmsford, MA

How will you make an impact?

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.

What will you do?

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

How will you get here?

BS degree required.

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

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.