Head of Quality & Regulatory – Aging & Caregiving
In this role, you have the opportunity to
The Head of Q&R for Aging and Caregiving (ACG) is the Director that will formulate and implement the business’s long range quality, regulatory and compliance policy, and to lead and direct organizational development and process. They will be responsible for; developing, maintaining, and implementing a quality strategy and system that meets the applicable regulatory requirements for the ACG products and sites, managing the daily activities of a global team, and ensuring that products meet or exceed the Philips quality standards.
You are responsible for
To formulate and implement the Business’ long-range quality, regulatory and compliance policy
Create Q&R awareness level as determined within the organization.
Enforces (a simplified) quality systems and harmonizes them across the Business sites in line with the Cluster; establish an effective Management Review process, including routine reporting.
Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.
Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations
Manages the review and approval of finished products manufactured for and •by the company in accordance with their approved specifications. Includes Complaint handling
Manages all inspections and questions relating to the operation of the manufacturing sites in coordination with all other applicable company groups.
Manages product recall activities to include recall policies and procedures for the company. Additionally, manage product compliant activities and processes.
Direct the Audit Program for the organization.
Drafts and manages the strategic improvement processes (‘breakthrough Program’) in the Business (One Page Strategy, Hoshin Plan).
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 environmental policies 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 the effective achievement of the company’s business objectives in full quality and regulatory compliance.
You are a part of
This position will report directly to the Head of Q&R Population Health Management, and dotted line report to the General Manager of ACG. The Head of Q&R ACG will serve as the management representative for the Population Insights & Care business.
The solutions that encompass Aging & Caregiving are:
CareSage predictive analytics
CareCensus care coordination services
CarePoint resident safety systems for senior living facilities
Philips Lifeline medical alert systems (HomeSafe, GoSafe)
Philips Automated Medication Dispensing Service
To succeed in this role, you should have the following skills and experience
A bachelor’s degree, preferably in a life sciences or engineering discipline.
Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), EU MDR, Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.
10+ years of related experience in a medical device, non-regulated, or consumer product regulations industry.
5+ years of management experience.
Demonstrated track record of team leadership, building teams, relationship management, and business development
Strong communication, interpersonal and presentation skills; detail-oriented
Proven experience in a matrix management of multiple operations
ASQ certification as Certified Quality Engineer or DfSS Green Belt / Black Belt a plus
Experience with Software as a Service, Platforms as a Service, Software as a Medical Device, embedded Software, non medical software development environments (consumer based / Health IT) and working knowledge of IEC 62304 and 82304.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
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, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.