In this role, you have the opportunity to
Develop and implement systems to ensure products or services are designed and produced to meet or exceed customer expectations.
You are responsible for
• Formulate and implement the Businesses long-term quality, regulatory and compliance policies.
• Manage a team of quality professionals assessing the performance of people and guide them for further individual development, setting goals for the area to encourage people to improve existing quality processes.
• Develop and support design transfer activities by implementing standardized quality centric launch practices the enable business strategies.
• Act as an agent of positive change, innovation and continuous quality improvement. Must be able to influence technical and non-technical senior leaders
• Create Q&R awareness level as determined within the organization
• Act as a contact person for ongoing NPI Projects to make sure to provide right amount of resources
• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle.
• Ensure 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
• Oversee all inspections and questions relating to the operation of the Business sites in coordination with all other applicable company and manufacturing groups.
• Manages product recall activities to include recall policies and procedures for the company. Additionally, manage product compliant activities and processes.
• Support and attend to internal and external Audits for the organization.
• Take initiative to establish Lean Philosophy within the Team to streamline daily business processes
• Interacting with Quality Managers across multiple businesses
• Keep the team up to date to regulatory requirements e.g. organize relevant trainings
• Can lead quality related problem solving and root cause analysis during design and manufacturing.
To succeed in this role, you should have the following skills and experience
• Bachelor's Degree or Masters’ in Engineering Discipline (EE, ME, Industrial etc..)
• At least 10 years' relevant occupation experience and 3+ years' experience as a functional (people) manager.
• 6+ years’ experience in FDA regulated Medical Device industry with design and manufacturing of Medical device Products and relevant ISO-Standards like ISO 13485, 21 CFR Part 820, ISO 14971.
• Demonstrated success in growing and coaching high performing engineering teams and leading change for product quality.
• Ability to lead, communicate, interact and influence effectively at technical and management levels across functions.
• Establishes a high level of continuous improvement philosophy
• ASQ certification as Certified Quality Engineer or demonstrated advanced lean manufacturing skills and experience.
• Hands on mentality to help people with the daily business
• Project Management certification or at least evidence of led Projects in the past
• Certified as an Auditor is a plus
• Travel required up to 15%
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 .
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.