Philips Head of Q&R Radiology Informatics in Pleasanton, California

To formulate and implement the Business’ long-range quality, regulatory and compliance policy

• Create Q&R awareness within the organization.

• Enforces the RI quality system; establishes an effective Management Review process, including routine reporting.

•Introduce and implement the quality processes and tools required to effectively ensure product quality and customer satisfaction.

•Manages compliance to FDA regulations and needed global Regulatory Agencies as required and assures RI products and operations are consistent with those regulations.

• Manages the review and approval of finished products by the BU in accordance with their approved specifications.

• Manages all internal and external inspections and questions relating to the RI Business sites in coordination with all other applicable company groups.

• In conjunction with the Head of PMS, manages product recall activities to include recall policies and procedures for the company. Additionally, manage product compliant processes.

Interact with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation.

• Ensures that all products to be released comply with all the relevant safety and regulations by implementing requirements, conditions and enablers in the Business.

• Participates with other senior managers to establish strategic plans and objectives.

• Makes final decisions on administrative or operational matters and ensures effective achievement of quality objectives .

• Has broad expertise or unique knowledge, uses skills to contribute to development of company objectives and to achieve goals in creative and effective ways.

• Has knowledge of all company products and services.

• Regularly interacts with executives. Interactions frequently involve special skills, such as working with management regarding matters of significance to the organization.

• Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Align Q&R AOP and schedules meet corporate requirements.

•Support Radiology Informatics Business from a quality and regulatory perspective, including adequate human resource allocation to projects.

  • Set and monitor Quality objectives , quality plans and quality KPI.

Head Q&R Radiology Informatics

In this role, you have the opportunity to

The Head of Q&R will work as the leader of a highly motivated team responsible for leading the complete product lifecycle to ensure success in terms of Quality. You will support various global cross functional teams as well as consult as a local Quality management System authority. You will lead the overall Quality and Regulatory strategy for Radiology Informatics

https://www.usa.philips.com/healthcare/solutions/clinical-informatics/radiology-informatics

You are responsible for

  • Implements and maintains the Radiology Informatics quality system; establishes an effective Management Review process, including routine reporting.

  • Introduce and implement the quality processes and tools required to effectively ensure product quality and customer satisfaction.

  • Leads compliance to FDA regulations and needed global Regulatory Agencies as required and assures products and operations are consistent with those regulations.

  • Leads the review and approval of finished products by the BU in accordance with their approved specifications.

  • Leads all internal and external inspections and questions relating to the Radiology Informatics Business sites in coordination with all other applicable company groups.

  • In conjunction with the Head of PMS, leads product recall activities to include recall policies and procedures for the company. Additionally, handle product compliant processes.

  • Interact with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation.

  • Ensures that all products to be released comply with all the relevant safety and regulations by implementing requirements, conditions and enablers in the Business.

  • Participates with other senior managers to establish strategic plans and objectives.

  • Makes final decisions on administrative or operational matters and ensures effective achievement of quality objectives.

  • Has broad expertise, uses skills to contribute to development of company objectives and to achieve goals in creative and effective ways.

  • Has knowledge of all company products and services.

  • Regularly interacts with executives. Interactions frequently involve special skills, such as working with management regarding matters of significance to the organization.

  • Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.

  • Align Q&R AOP and schedules meet corporate requirements.

  • Support Radiology Informatics Business from a quality and regulatory perspective, including adequate human resource allocation to projects.

  • Set and monitor Quality objectives, quality plans and quality critical metrics.

You are a part of

The Philips' Radiology Informatics (RI) Business provides a comprehensive solution for medical image storage, enterprise distribution, and enterprise workflow. We will be redefining what is possible, finding answers to some of the domain s toughest problems.

To succeed in this role, you should have the following skills and experience

  • Bachelor’s degree with at least 5 years of related experience in Quality Assurance

  • Working knowledge of global regulations, requirements, and standards including ISO 13485, IEC 62304, ISO14971 and 21 CFR Parts 803, 806. Including working experience of FDA Quality System Regulations

  • Medical domain knowledge of DICOM, HL7, PACS is preferred, not required

  • Government/regulatory-body Quality System audit experience

  • Experience leading global Quality & Regulatory teams or projects in a matrixed environment

  • Possess strong interpersonal and organizational influencing skills

  • Shown success leading and influencing cross-functional peers

  • Strong written and verbal communication as well as project management skills

  • Experience working in a global, team driven, collaborative environment

In return, we offer you

The opportunity to contribute to culture-change and define processes within the organization. This position has high-visibility and will collaborate with multiple partners globally.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, passionate about improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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.

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