Bruker · 2 days ago

Quality Assurance Associate

Bothell, WA

Full-time

Onsite

Mid Level

$62K/yr - $85K/yr

3+ years exp

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ChemicalLife Science

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Responsibilities

Administer the Change Management and Document Control system.

Perform QA product release.

Lead creation and modification updates for SOPs, work instructions, and other quality documentation.

Review quality records for completeness and compliance with QSR and ISO requirements.

Assist Quality Management with various projects, as required

Support the eQMS electronic documentation system, as needed

Conduct, participate, and support internal quality audits, process/product improvement projects, and disposition activities

Participates in FDA/ISO inspections and customer audits

Perform other relevant duties as may be assigned by management.

Qualification

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ISO 13485FDA RegulationsLead Auditor CertificationQuality Systems ManagementChange ManagementDocument ControlRoot Cause AnalysisTraining SkillsProblem SolvingInterpersonal SkillsCommunicationMedical Device IndustryDiagnostic Industry

Required

Bachelor’s degree in a related field strongly preferred

3-5 years quality-related experience in the pharmaceutical or device industry

Good knowledge and skills in using advanced personal computer productivity programs for word processing, spreadsheets, database manipulations, and flow charts

Demonstrates working knowledge of ISO 13485 quality system and/or FDA 21 CFR 820 quality regulations

Good written and verbal communication skills

Interpersonal skills to interface with all levels of the organization, management, customers, and suppliers

Lead Auditor Certification

Strong understanding of applicable regulations and standards (21 CFR 803, 806, 820, and ISO 13485)

Problem Solving and training skills

Practical experience/training in quality systems management, change management and document control processes, quality auditing, root cause analysis, and problem-solving are highly desirable