Senior Quality Lead - Quality Compliance

Your role:

• Act as Subject Matter Expert (SME) for non-conformance, driving non-conformance reduction and process validation maturity in close cooperation with Quality leads in the Integrated Supply Chain.
• Implement and provide oversight of consistent global Quality and Regulatory requirements related to elements supporting overall operations and process controls.
• Ensure appropriate standards and processes are in place for new product introduction and ongoing manufacturing, covering all stages of product/system manufacture.
• Oversee Quality Assurance activities in processes related to the manufacturing of materials, components, sub-assemblies, and completed products and their supply chain, ensuring compliance with regulatory requirements and procedures for regulated products/businesses.
• Impact processes such as the introduction/validation of new or changed manufacturing processes and their associated Quality systems, trend analysis and monitoring of manufacturing processes and their environment, remediation to non-conformances, and the development and improvement of Quality systems.
• Serve as a best practice/quality resource within your discipline or as a technical expert on functional or cross-functional teams/projects, acting on a global scale across all Philips businesses and factories.
• This flexible role offers the opportunity to work with international teams, benefiting from an office-based working model (at least 3 days in the office and up to 2 days from home). Global travel between 20-30% is required for strategic and key initiatives, as well as leadership activities.

You're the right fit if:

• You have 5+ years of experience in quality engineering, with a comprehensive understanding of manufacturing and operations, and a proven ability to resolve a wide range of issues creatively, including introducing new concepts. You demonstrate a relentless focus on Product Quality and Patient Safety, strong leadership skills, and the ability to influence change and challenge the status quo for improvement opportunities.
• You possess strong knowledge of principles, theories, and concepts relevant to Quality Engineering (CQE body of knowledge), and working knowledge of global medical device regulations, requirements, and standards. You are skilled in Risk Management, Acceptance activities, Non-Conformance, Production and Process Controls, and Process Validation activities.
• You hold a bachelor’s degree or higher in Engineering or a related field (such as Mathematics or Statistics), and are Lean Six Sigma Green or Black Belt (or Master Black Belt) certified.
• You are able to successfully perform the minimum Physical, Cognitive, and Environmental job requirements for this position, with or without accommodation.
• You are an excellent communicator with strong negotiation and relationship management skills, and have the ability to make data-driven decisions and guide teams through ambiguous and complex situations to develop clearly defined programs. You must be willing and able to travel to the US, Europe, India, and China up to 25%.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

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.