Title: Quality Engineer
Duration - 1-year duration, possibility to extend or convert.
Location: New Kensington PA
Medical Device Experience is Mandate
Only W2
Key Areas of Responsibility:
- 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 of manufacturing process or controls and:
- NC/QN Management Process.
- Analysis of defect for determining the disposition of non-conformances
- Contribute to Operations performance monitoring, reporting, improvement, and development.
- Responsible for improvement programs in the 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 regarding non-conformance disposition management
Job Overview:
- Responsible with Change Management to manufacturing process or controls and: NC/QN Management Process. Analysis of defects for determining the disposition of non-conformances Contributes to Operations performance monitoring, reporting, improvement, and development. Responsible for improvement programs in the factory. Assists Supplier Quality with investigations and may assist with Supplier Communications, as required.
- Led change management for process changes in the factory Responsible for nonconformance events and investigations in the Factory and Oversees Material Review board activities for non-conformance disposition management
- Developing professional expertise, and applying company policies and procedures to resolve a variety of issues. Fully qualified managers who have advanced beyond entry level. Has working knowledge of company products and services. Frequently interacts with subordinate supervisors and functional peer groups. Interaction normally requires the ability to Product cooperation of others, conducting presentations of technical information concerning specific projects or schedules.
- Works on issues of diverse Products where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business Trends. Follows processes and operational policies in selecting methods and techniques for obtaining solutions
Education Requirements: Bachelor’s degree in Engineering Science, or equivalent experience
Required EXP: 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