Senior Quality Assurance Engineer (781089)

Ensure new or modified products conform to quality standards and establish compliance with the quality system, Quality System Regulations, ISO 13485, ISO 14971, and other applicable standards/regulations throughout the design transfer to manufacturing process as well as product lifecycle. Improve awareness, visibility, and communication on quality initiatives to support departmental, functional, and corporate quality goals/priorities. Establish quality deliverables and ensure timely execution to support new product introductions as well as design changes to existing products, using project plans. Support Risk Management activities from design to manufacturing risks as well as DMR content completion, integrity, and compliance. Identify gaps, communicate and work with team to resolve the same. Review process validation, engineering studies, project planning documents. Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems. Resolve testing problems by modifying testing methods or revising test objectives and standards. Job Requirements: Requires a Bachelor's degree (or foreign equivalent) in Biomedical Engineering, Plastics Engineering, Polymer Engineering a directly related field, plus five (5) years of experience in a FDA regulated environment. Experience must include: Five (5) years of experience in the following (experience may be gained concurrently): • Experience with FDA ISO 13485 and ISO 14971 regulated, medical device industry. • Statistical methods, including statistical process control, sampling plans (AQL), gage R&R, design of experiments, and capability analysis. • Corrective and Preventative Action • Incoming, in-process, and final inspection development • Process Validation, IQ/OQ/ PQ/TMV • Root cause analysis of non-conformances • Internal and external audit support • ETO sterilization Please copy and paste your resume in the email body (do not send attachments, we cannot open them) and email it to candidates at placementservicesusa.com with reference #781089 in the subject line. Thank you.