Sr. Quality Systems Engineer
In this role, you have the opportunity to
Make a substantial contribution to the improvement and maintenance of the Philips Ultrasound QMS.
You are responsible for
Facilitate the Corrective and Preventive Action (CAPA) program by leading and mentoring cross-functional teams through appropriate root cause analysis and action plan development and identification of effectiveness criteria. Responsible for maintaining CAPA records and keeping them in a state of audit readiness.
Apply sound, systematic problem-solving methodologies in identifying, communicating, and resolving quality issues.
Partner with cross-functional Process Owners to ensure effective and efficient deployment and documentation of processes within the QMS, including development of effective training solutions.
Provide support for Ultrasound audits including internal, corporate, customer, and regulatory. May serve as Subject Matter Expert in audits.
Participate and/or Lead quality system standardization activities.
Execute on quality and regulatory compliance strategies to maintain compliance and adapt the QMS to the continuously evolving external regulatory environment.
You are a part of
The Philips Ultrasound Team. Our mission is to improve the lives of 3 billion people per year by 2030. Every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Our QMS is an enabler for this mission.
To succeed in this role, you should have the following skills and experience
A minimum of a Bachelor's Degree in a Science/Engineering or other relevant technical discipline with 8 years of experience working in quality at a medical device design/manufacturer
Six Sigma training/certification is a plus
Thorough knowledge and understanding of global Medical Device standards and regulations including FDA QSR and ISO13485:2016
Experience leading and/or participating in quality software validation
Ability to interact professionally with all organizational levels
Must be results-driven - Able to manage competing priorities in a fast-paced environment
Ability to communicate ideas and information clearly, effectively and concisely
Highly detailed oriented with strong organization and prioritization skills
In return, we offer you
The opportunity to work in a global environment – partnering across functions, teams, businesses and geographies. You will be challenged to support and deploy changes to the QMS needed to meet the ever-evolving regulatory requirements for Medical Device manufacturers.
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 . 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 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 .
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.