Senior Quality Lead-Quality Compliance

Koninklijke Philips N.V•Cambridge, MA

21d•$114,750 - $205,632•Onsite

About The Position

The Senior Quality Lead-Quality Compliance acts as Subject Matter Expert (SME) for non-conformance, driving non-conformance reduction and process validation maturity in close cooperation with the Quality leads in Philips Integrated Supply Chain (ISC)anization. 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 includes all stages of the manufacture of the product/system. Oversee the Quality Assurance activities in the processes related to the manufacturing of materials,ponents, sub-assemblies, andpleted products and their supply chain, includingpliance 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, trend analysis and monitoring of manufacturing processes and their environment, remediation to non-conformances, and the development and improvement of Quality systems. Serve as best practice/quality resource within your own discipline or as technical expert on functional or cross-functional teams/projects. You also act on a global scale across all Philips businesses and factories.

Requirements

You've acquired a minimum of 7+ years' experience in quality engineering within FDA regulated medical device manufacturing environments, with a full understanding of manufacturing operations, and proven expertise in non-conformance, driving non-conformance reduction and process validation.
You're able to utilize creative problem-solving techniques in resolving a wide range of issues and introduce new techniques/approaches to problem solving.
You have a relentless focus on Product Quality and Patient Safety, with demonstrated leadership skills, and ability to influence change and challenge status quo in respect to opportunities for improvement.
Your skills include strong knowledge of principles, theories, and concepts relevant to Quality Engineering (CQE body of knowledge)
You have detailed knowledge of appropriate global medical device regulations, requirements and standards including 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), etc.
You have strong knowledge of Risk Management (ISO 14971, FMEA), Acceptance activities, Non-Conformance, Production and Process Controls, and Process Validation activities.
You have a Minimum of a Bachelor's Degree (Required) in Quality, Engineering or related field (Mathematics, Statistics, etc.), and are Lean Six Sigma Black Belt or Master Black Belt certified.
You're an excellentmunicator with strong negotiation and relationship management skills, with a strong ability to make data-driven decisions and move teams through vague andplex situations to develop clearly defined programs.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without amodation for this position.

Responsibilities

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 includes all stages of the manufacture of the product/system.
Oversee the Quality Assurance activities in the processes related to the manufacturing of materials,ponents, sub-assemblies, andpleted products and their supply chain, includingpliance 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, trend analysis and monitoring of manufacturing processes and their environment, remediation to non-conformances, and the development and improvement of Quality systems.
Serve as best practice/quality resource within your own discipline or as technical expert on functional or cross-functional teams/projects.
Act on a global scale across all Philips businesses and factories.