Quality Engineer - Manufacturing & Operations
Job DescriptionYou will play an instrumental role in achieving a state of high quality performance, compliance and sustainability in the Philips Micro Device facility, while pursuing continuous quality improvement through the application of Quality Engineering practices.
Your role:
- Ensuring the Quality Management System requirements related to overall manufacturing, operations and process controls are established, maintained and executed
- Ensuring that appropriate standards and processes are in place for new product introduction, as well as for ongoing manufacturing that include all stages of the manufacture of the product/system
- Frequently interact with functional peers and upper management normally involving Manufacturing and Operational matters between functional areas, other Business Groups / Units, or customers
- Oversees the Quality Assurance in the processes related to the manufacturing of materials, components, sub-assemblies, and completed products and their supply chain, including compliance to regulatory requirements and/or procedures for regulated products/businesses
- Have an impact on processes such as theintroduction/validationof new/changed manufacturing processes and their associated Quality systems, the trend analysis and monitoring of manufacturing processes and their environment, the remediation to non-conformances, and the development and improvement of Quality systems
- Ensuring Partnership with Supplier Quality on Purchasing Controls processes
- Management of Non- Conformances events
- Partner with other members of the Quality team to manage connected processes such as NC, CAPA, Complaint Management, Performance Trending
- Supports Receiving Inspection /WIP inspection/ FG Release
- Supports Transfer Integrations - Manages or supports ship hold activities
- Support internal and external audits as Quality representative for manufacturing and operations
You're the right fit if:
- Good knowledge of Risk Management, Acceptance Activities, Non-Conformance, Production and Process Controls, and Process Validation activities
- Good understanding of manufacturing and operations, resolving a wide range of issues in creative ways, including the introduction of new concepts
- Working knowledge of appropriate global medical device regulations, requirements, and standards
- Good knowledge and understanding of principles, theories, and concepts relevant to Quality Engineering
- Identifying technical gaps and taking action to address them
- Relentless focus on Product Quality and Patient Safety as an organizational value
- Ability to influence change and challenge status quo with respect to opportunities for improvement
- Negotiating and relationship management skills
- Data-driven decision-making and the ability to move teams through vague and complex situations to develop clearly defined programs
- English mandatory, Dutch preferred
• Learn more about .
• Discover .
• Learn more about .