Job Description

Overview

Develop/implement/ review quality standards, control plans, PFMEA and testing procedures for new and existing equipment.

Responsibilities

Lead product and process risk analysis and mitigation development efforts to confirm the design and process team has accurately identified product & process risk, assessed the level of risk and analyzed with team to ensure the risks are assessed.

Assure acceptance and methodologies are fully documented and appropriate such that product inspection / validation / testing is properly performed, including develop, maintain and revise validation / test requirements.

Plan and perform process audits internally to ensure compliance per processes and system requirements.

Data Analysis & Improvement

Monitor KPIs, analyse production data, perform root cause analysis (RCA), and drive continuous improvement.

Identify opportunities to enhance efficiency, reduce defects, and improv...

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