QA Engineer III
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: New Kensington, PA 15068
Description:
Responsibilities:
- Non-Conformances events including CAPA management when required.
- Local Factory level QMS Process owner for Process validation.
- Partner with SQ on incoming, outgoing, WIP Receiving Inspection /WIP inspection /FG Release Transfer Integrations Resolve quality non-conformities with Philips internal suppliers.
- Analytical Testing Support SQE/SQA/Purchasing Product Ship Holds & Communications.
- Responsible with Change Management to the manufacturing process or controls and NC/QN Management Process.
- Analysis of defects for determining disposition of non-conformances.
- Contribute to Operations performance monitoring, reporting, improvement, and development.
- Responsible with improvement programs in factory.
- Assists Supplier Quality with investigations and may assist with Supplier Communications, as required. Leads change management for process changes in the factory.
- Responsible for nonconformance events and investigations in the Factory.
- Oversees Material.
- Review board activities non-conformance disposition management.
- Bachelor's degree in engineering science, or equivalent experience
- Minimum of 5 years of related engineering experience (medical device or regulated industry preferred).
- Wide-ranging experience within an engineering function.
- Well-versed in Quality Engineering and Continuous Improvement techniques.
- Direct working relationships with suppliers - Participated in several NPIs from start to finish.
- Direct shop-floor production engineering sustaining experience.