In this role, you have the opportunity to
Build and lead the Quality Assurance and Quality Engineering teams (Q&R) for the newly acquired Philips manufacturing facility in Minnesota. You will support site Business Units in transfer, installation and validation, beginning with a Class III combination device.
You are responsible for
Provide QA leadership to projects and quality systems to maintain the lifecycle of the product or system.
Develop Quality Improvement projects for the site, including formal quality efforts such as CAPA , NCMR, OOS and Audit Responses.
Manage the team to ensure product safety and support of the Quality Management System.
Responsible for ensuring business Key Performance Indicators (KPIs) and QMS metrics are defined, evaluated and actions taken so that commitments are met.
Oversee implementation of Philips software tools and processes that support quality improvement efforts.
Ensure Risk Management is effective utilizing feedback from manufacturing indicators, CAPA’s, HHE’s etc.
Provide expert knowledge regarding Root Cause Analysis, Effectiveness Criteria and documentation of quality improvement efforts in alignment with regulatory requirements.
Able to provide expert knowledge of 21 CFR part 820 FDA requirements for Medical devices and ISO13485.
To succeed in this role, you should have the following skills and experience
BS in Engineering, Life Science or other related field
Minimum of 5 years of work experience in medical device or pharmaceutical industry
Knowledge with product transfers (facility to facility and product development to commercialization)
Experience with FDA 21 CFR part 820 requirements, ISO 13485, ISO 14971 and familiarity with 21CFR part 4- Regulation of Combination Products or 21CFR part 211- Current Good Manufacturing Practice for Finished Pharmaceuticals and EUMDR.
Utilize Quality Engineering tools and techniques to establish sampling plans, root cause analysis and process control monitoring.
Proven record to attract, retain and develop talent.
Regularly interacts with senior management or executive levels on matters concerning several functional areas and/or customers.
Manage and accomplish tasks under high pressure within a fast pace environment.
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.
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.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.