You are responsible for:

• Responsible for leading design quality teams for activities to include compliant application of Design controls providing independent oversight of all design related and risk activities during product/system lifecycle including design V &V activities, design transfer, and product realization. 
• Responsible for developing quality plans, overseeing the execution of quality plans, assessing complex product design, reviewing test and other complex performance data, analyses market feedback, lead complex root cause analysis and complex quality problem solving.
• Responsible for overall collaboration with Product System Architecture Quality for Sleep and Respiratory product portfolio.
• Responsible for Risk Management Activities (FMEAs, hazard analysis, fault tree analysis) throughout the lifecycle of product portfolio which includes both pre-market and post-market.
• Responsible for post-market data analytics and statistics to report on product quality performance and post-market quality analysis.  This involves trending, reporting, and action to demonstrate alignment to key performance indicators (KPI).
• Support post market risk assessment activities to include CAPA, IIA, HHE, and Complaint analysis as necessary.  Performs independent technical assessment on product quality performance and post-market product quality analysis.
• Establishes and assures adherence to budgets, schedules, work plans, and performance requirements
• May lead quality related problem solving and root cause analysis during design and manufacturing.
• Conduct annual performance reviews, manage talent development, and succession planning to ensure we have the best talent within the organization.
• Interactions frequently involve negotiating with customers, management, and interfacing with senior/executive level leaders regarding matters of significance to the organization.
  
  

You are part of:

Sleep & Respiratory Care Business Group, a business group of Philips HealthTech. We are highly dynamic, ambitious, and agile within a fast-changing industry. Our vision is to work together with our clinical and consumer customers to transform the personalized healthcare market to meet the significant demands caused by the increase of chronic conditions and an aging society. Our mission is to improve the quality of life for consumers and patients through better awareness, diagnosis, treatment, monitoring, and management of their conditions.  This position reports directly to the Head of Quality Engineering for SRC. 

To succeed in this role, you’ll need a customer-first attitude and the following

• Minimum of 7+ years’ experience leading design quality teams with a focus in application of Design controls providing independent oversight of all design related and risk management (ISO 14971) activities during product/system lifecycle including: design V&V, design transfer, and product realization
• Minimum of a Bachelor's degree in Engineering-Electrical, Mechanical, Software Engineering or related technical disciplines (Masters degree preferred)
• Electrical and software development experience is preferred
• Strong understanding of medical device regulations and requirements, ability to project manage multiple tasks, strong emphasis on exceeding customer expectations, while maximizing value, and maintaining FDA/ISO, EU MDR, and other regulatory compliance
• Proven ability to deliver results, and ability to consistently meet and/or exceed goals.
• Maintains a culture of accountability, integrity, and high expectations - leads by example.  Champions for patient safety and customer first best practices, while exhibiting uncompromised ethics and integrity.
• Leadership experience and good change management and influencing skills required.  Ability to lead by example, foster an environment of responsibility and accountability.
• Proven expertise with Design Quality, Reliability and Safety/Compliance is a must.
• ASQ certifications (CQE, CRE, CMQ/OE etc) Preferred.
• Strong working knowledge of medical device industry regulatory requirements including but not limited to MDSAP participating countries, ISO Standards (ISO 13485 and ISO 14971), EUMDR, IEC 62304, IEC 60601, IEC 62366.
• Proven expertise in risk management principles and the application of ISO14971 for all phases of the product lifecycle is essential
• Excellent organizational skills to lead and track deliverables
• Ability to clearly connect with your team to set direction and to communicate concisely with senior management to provide periodic updates
• Effective team leader. Able to mentor and empower a team, set strategy and evaluate proficiencies present and needed for department growth.

About Royal Philips Royal Philips (NYSE: PHG, AEX: PHIA) is a leading healt h technology company focused on improving people’s health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. The company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips’ wholly owned subsidiary Philips Lighting is the global leader in lighting products, systems and services. Headquartered in the Netherlands, Philips posted 2015 sales of EUR 24.2 billion and employs approximately 104,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.