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:
· Leads a cross-functional team of direct reports that is responsible for the predictable on-time & high-quality development, sustaining and continuous improvement of world-class Computed Tomography (CT) and Advanced Molecular Imaging (AMI) products.
· Responsible for leading the filed action sustaining team to ensure customer satisfaction through investigation and resolution of issues escalated by complaint handling and support teams.
· Responsible for interfacing with other departments for specialized skill sets not present in the field action team to grow the skillset of the team and to utilize those specialized skills to solve customer issues and complete development projects.
· Continuously improves the quality of the output and processes utilized by the team.
· Develops and tracks metrics to define the success of the team.
· Supervises, selects, develops, coaches and evaluates personnel to ensure the efficient operation of the department and growth of the employees.
· Establishes and controls the budget for the department.
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.
Location: Cleveland, Ohio
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:
· Master’s degree in technical field or equivalent with > 10 years of related experience.
· Demonstrated experience leading cross-functional teams to deliver high-quality on time and on budget product releases.
· Computer-literate with working knowledge of Microsoft Project, Microsoft Excel, PowerPoint, and Word required.
· Strong problem-solving skills required
· Strong written and verbal communication skills required
· Demonstrated motivational skills and the ability to lead by influence.
Preferred Requirements:
· Demonstrated experience applying Lean or Six Sigma with working knowledge of Six Sigma tools (such as Minitab) to generate business results preferred.
· Experience in a FDA or similarly regulated device (FAA, Mil Spec, etc.) environment preferred
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