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Senior Quality Engineer
2 maanden geleden
Job Title
Senior Quality Engineer - Process Validation
Job Description
You promote and implement organizational policies & standards to ensure product quality through design transfer, manufacturing and distribution, in compliance with regulatory requirements and Philips' Business Systems. You act on a global scenario across all Philips businesses and factories.
You bring in-depth knowledge of process validation and leadership skills to mature this process across all Philips sites.
Your role:
Implement and provide oversight of consistent global Quality and Regulatory requirements related to elements supporting the overall operations and process controls
Ensures 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 the introduction/validation of 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.
You serve as best practice/quality resource within your own discipline or as technical expert on functional or cross-functional teams or projects
You act on a global scenario across all Philips businesses and factories, however focus areas will be Europe and Asia
You're the right fit if
Strong knowledge and understanding of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
Prior experience with large and complex quality continuous improvement programs and projects, with demonstrated success and impact on quality KPI’s
Experienced professional with a full 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
Strong knowledge of Risk Management, Acceptance Activities, Non-Conformance, Production and Process Controls, and Process Validation activities
Identifies technical gaps and takes action to address them
Relentless focus on Product Quality and Patient Safety as an organizational value
Demonstrated leadership skills, 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
You are willing to travel to Europe, India and China approximately 15/25% of the time
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .
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