Quality Assurance Engineer

Provide risk management and design control guidance for design quality assurance activities on medical device projects and coordinate quality activities with engineering, clinical, sourcing, manufacturing, distribution, service, and support teams. 
 
 To support the worldwide regulatory requirements through product submission, registration and continued compliance through complete life cycle of medical devices. 
 
 To provide regulatory and quality input for medical device products from generation through release to obsolescence assisting in planning, developing and quality support in projects. 
 
 To support quality control requirements, supplier quality, complaints, post market support, audit, non-conforming materials, CAPA systems and process risk. 
 As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve. 
 
 Responsibilities 
 Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA). 
 Key areas of responsibilities (KARS) for this role include: 
 
 o Provide QA resource to product support to ensure regulatory compliance of post market products. 
 o Ensure that projects to develop medical devices follow applicable company policies, procedures, standards and regulations. 
 o Ensure that released devices are safe and effective and meet their intended use. 
 o Assist in production and market of product in investigating and reporting the results of investigations for reported technical problems as part of corrective actions. 
 o Support the investigation of vigilance and reportable events and reporting of the results of the investigations to corporate and regulatory authorities. 
 o Travel to assist in customer, internal and supplier audits where required either in the US or internationally. 
 o Manage auditing of internal and supplier quality systems to ensure effectiveness of the quality management system. 
 o Assist in improving the culture of all staff in Quality & Regulatory requirements of the Medical Device Requirements. 
 o Support the QARA Manager in quality and regulatory decisions as required and other relevant tasks as may be reasonably requested of the QARA Manager. 
 o Manage safety risks associated with medical devices in accordance with applicable standards. 
 o Facilitate usability analysis and activities in accordance with applicable standards. 
 o Represent QA on product defect review boards, and change control boards. 
 o Help coach project teams on use of quality system. 
 o Prepare for and participate in project and quality systems audits and inspections. 
 o Proactively participate in design reviews, quality business reviews and post market improvement teams. 
 o Support the worldwide regulatory requirements through product submission, registration and continued compliance through complete life cycle of medical devices. 
 o Assist in investigating and reporting the results of investigations for reported technical problems as part of corrective actions. 
 o Provide risk management and design control guidance for design quality assurance activities on medical device projects and coordinate quality activities with engineering, clinical, sourcing, manufacturing, distribution, service, and support teams. 
 o To support the worldwide regulatory requirements through product submission, registration and continued compliance through complete life cycle of medical devices. 
 o To provide regulatory and quality input for medical device products from generation through release to obsolescence assisting in planning, developing and quality support in projects. 
 o To support quality control requirements, supplier quality, complaints, post market support, audit, non-conforming materials, CAPA systems and process risk. 

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