RBW Consulting · 2 days ago

Quality Engineer

Devens, MA

Full-time

Onsite

Senior Level

10+ years exp

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ConsultingHealth Care

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Hiring Manager

Cloé Broad

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Responsibilities

Create and maintain pFMEAs, Control Plans, PPAPs, Master Validation Plans, IQ/OQ/PQ protocols, and reports.

Analyze FAIRs, process, and test method validation data before sending to the customer.

Lead customer complaint and CAPA investigations as required.

Manage ECOs, deviations, and documentation updates as required.

Generate and maintain applicable quality system documentation as needed.

Manage activities for handling healthcare products from receiving to shipping.

Assess and ensure compliance through training, auditing, and corrective and preventive actions.

Participate in customer audits and provide input to any observations.

Train personnel as required.

Review and discuss daily rejects and implement action plans.

Make appropriate changes to prevent recurrence of quality-related issues.

Make appropriate changes to fixtures or inspection methods and tools as required.

Maintain regular attendance and professionalism.

Qualification

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ISO 1348521 CFR Part 8202D drawingsInspection equipmentComputer skillsWordExcelSPCHealthcare industry experience21 CFR Part 820 Quality System RegulationProblem-solvingInterpersonalLeadershipManagerialCollaborative