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Responsibilities:

You will work closely with operations and the business functions to ensure quality performance of product and processes.
You will collaborate with divisional QA and supplier teams to address top quality issues cross functionally
You will own identified internal and supplier non-conformances and manage the timely closure of NC's.
You will own identified internal CAPAs and manage to timely root cause investigation, implementation, and closure.
You will disposition non-conforming product within MRB, issuing NC's as appropriate.
You will develop and improve internal manufacturing processes for existing products.
You will perform PPAP activities for supplier changes
You will maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
You will support and drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
You will engage and interface in internal and external audits providing subject matter expertise
You will support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
You will be responsible for initiation, internal containment, and support of Commercial Holds for potential product escapes.

Requirements:

Bachelor's degree in Engineering or related discipline (Electrical Engineering highly preferred)
0+ years of experience in quality and/or manufacturing engineering a must
Experience in electronics (PCBAs, flex boards, soldering, etc.) highly preferred
Production process controls experience preferred
Validation knowledge/experience (PPAP, IQ/OQ/PQ) preferred
MS, CQE, or CRE preferred.
Six Sigma Green or Black belt preferred.
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.

Katalyst HealthCares & Life Sciences Inc

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