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About the Role:
We are seeking a highly skilled Senior Quality Assurance Manager to join our team at Philips. As a key member of our organization, you will be responsible for promoting and implementing organizational policies and standards to ensure product quality through design transfer, manufacturing, and distribution, in compliance with regulatory requirements and Philips' Business Systems.
Your Key Responsibilities:
- Implement and provide oversight of consistent global Quality and Regulatory requirements related to elements supporting the overall operations and process controls.
- Ensure 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.
- Oversee 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 will serve as a best practice/quality resource within your own discipline or as a technical expert on functional or cross-functional teams or projects.
- You will act on a global scenario across all Philips businesses and factories, however focus areas will be Europe and Asia.
Requirements:
- 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.
