myGwork - LGBTQ+ Business Community · 1 week ago

Engineer III, QA

Frederick, MD

Full-time

Onsite

Entry, Mid Level

2+ years exp

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Responsibilities

Working with multi-functional departments for investigations, corrections/corrective actions to ensure accurate documentation and closure, provide trending and issues as appropriate.

Analyze and trend all types of data (CAPA, problem records, complaints, on market surveillance) to identify deficient areas and initiate quality improvement projects.

Participate in third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformities.

Write, review, and approve CAPAs to ensure timely resolution of quality problems.

Promote and implement improvements and compliance with site Quality Management System requirements.

Prepare clearly written business communications.

Write, review, analyze and revise written relevant Stand Operating Procedures (SOPs) and submit procedural changes as needed to meet site, regulatory requirements.

Support the quality department as assigned.

Qualification

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ISO 13485GMPQuality AssuranceQuality SystemsQuality EngineerDigital literacyAgileTrackwiseE1Quality toolsMethodologiesRoot cause analysisRegulatory requirementsBusiness requirementsWork prioritizationProblem-solvingOrganizationalPositive demeanor