Senior Quality Lead-Quality Compliance

Senior Quality Lead-Quality Compliance page is loaded## Senior Quality Lead-Quality Compliance locations:
Cambridge (US):
New Kensington:
Murrysville:
Plymouth:
Latham time type:
Full time posted on:
Posted Todayjob requisition :
567283### Job Title Senior Quality Lead-Quality Compliance###

Job Description 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) organization.
** 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, 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, 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.
** You're the right fit if:
*** 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 excellent communicator with strong negotiation and relationship management skills, with a strong ability to make data-driven decisions and move teams through vague and complex 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 accommodation for this **.
**** How we work together:
** We believe that we are better together than a part. 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.
** This is an Office role.
**** About Philips:
** We are a health technology company. We built our entire company around the belief that every human matters, and we…