Senior Manager, Design Assurance

Sr. Manager, Design Assurance
Your challenge
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.
The Senior Manager, Design Assurance will oversee the development of medical devices and components by providing direction on applicable design control processes across the Philips Patient Care and Monitoring Solutions (PCMS) Business Sector. This position will engage with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation assuring the design control system is effectively established, executed, and maintained. Working in a matrix environment, this position will be responsible for leadership and guidance to the Design Quality team in design control related matters to ensure compliance to regulatory requirements.
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:
Actively participate in the formulation and implementation the Business? long-range Design Assurance & Risk Management policies and procedures.
Drafts and manages the strategic Design Assurance improvement processes in the Business (One Page Strategy, Hoshin Plan).
Ensures appropriate reliability criteria are established and that sufficient testing is performed to achieve reliability goals with a high level of assurance.
As a people manager responsible to attract, develop, engage and retain team members. Drive ambition towards our vision, act as a coach and co-own the career development plans of Design Assurance team members.
Introduce and implement the Design Assurance processes and tools required to ensure product quality and customer satisfaction.
Enforces Design Assurance quality systems and harmonizes them across the PCMS Business sites and Sector; establish an effective Design Assurance review process, including routine reporting.
Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
Your team
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
Philips Patient Care and Monitoring Solutions (PCMS) Business Sector
We are looking for:
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We?re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.
Specific skill requirements for this role include:
Minimum Education: Bachelor?s or Master?s degree in Math, Statistics, or Engineering.
Minimum Experience: 10 years of experience in a technical function with 5 years of managerial experience. 5 years of experience in a medical device or regulated industry quality role.
Specialized Knowledge:
Demonstrated experience in the practical and effective implementation of Design Control processes, problem solving and root cause analysis (good understanding of physics of failure), predictive modeling and failure mode analysis, as well as accelerated reliability testing methods.
Established knowledge of ISO and FDA quality and system requirements, reliability engineering industry standards;
Influential leader with demonstrated experience in change management, track record of team building & mature communication skills.
Special Skills:
Training in advanced statistical techniques (Six Sigma Black Belt preferred), ASQ Certified Reliability Engineer, advanced software skills such as MiniTab, Office Suite.
Our offer
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that?s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role?s mission, you will have an array of diverse career options open to you ? across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
Find out more info about Philips at www.philips.com/na/careers
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