Factory Quality Leader, Bothell
As a Factory Quality Leader, you will have responsibility to oversee Quality Assurance in the processes related to the manufacturing of materials, components, sub-assemblies, and completed products and their supply chain, including compliance to regulatory requirements and/or procedures for regulated products/businesses. The processes include the introduction/validation of new/changed manufacturing processes and their associated Quality systems, the trend analysis and monitoring of manufacturing processes and their environment, the remediation to non-conformances, and the development and improvement of Quality Systems.
You are responsible for
As the incumbent of this Quality Manufacturing role within Philips, your challenge will be to lead the Quality team in Bothell and enable functions to always do the right thing. This involves being a confident advisor on process improvement, regulatory compliance and quality management related topics, in order to support manufacturing of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
Key areas of responsibilities for this role include:
Directs activities of the Quality Department including but not limited to Operations, Document Control, CAPA, Complaints Investigations, Calibration, and various other compliance related functions.
Partner with stakeholders to drive productivity & improvements to products, processes and behaviors across the Integrated Supply Chain.
Partner with Factory Leaders to execute strategy for sustaining and improving existing production lines at the site.
Maintain compliance and consistently operate in a state of substantial compliance.
Manage external audits of the factories and/or customer audits, as applicable.
Ensures implementation, effectiveness, and integrity of the Quality System that is compliant to all applicable standards and regulations to support the products on the market.
Ensures quality metrics (e.g. post market, manufacturing and inspection) and key process indicators are identified, measured and action driven. Identify unacceptable trends and applies suitable corrective action in order to meet strategic objectives.
Facilitates the NCR/CAPA process (e.g. assigns CAPA investigations, reviews CAPA plans, and implementations).
Responsible for Site Quality Control (e.g. Incoming/In Process/Final Inspection, Non-conforming Material, and Calibration Systems).
Responsible for ensuring complete and sustainable implementation of an effective internal audit program.
Develop quality planning/objectives, metrics and goals; lead efforts related to the company’s Quality Vision.
Manage site quality budget to ensure that all areas of Quality are resourced and are capable to fulfill day-to-day operations.
Develop competency and capability to execute within the Integrated Supply Chain model.
Provide support and, where necessary, lead corporate-wide Quality Systems’ initiatives.
You are part of
Philips is one of the world's leading healthcare technology companies. We are committed to understanding the technological and human needs of patients and caregivers and to delivering solutions that enable more confident diagnoses, more efficient delivery of care, and more positive user experiences. People focused. Healthcare simplified.
Skills and experience
We are looking for a person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people the Philips brand touches each year.
Specific skill requirements for this role include:
A Bachelor’s degree in engineering or science or equivalent experience in the medical device industry
5+ years of related experience.
Working knowledge of appropriate global regulations, requirements, and standards.
ASQ certified Quality Engineer desired.
Have an understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
Have understanding of a Quality System and its development, documentation, and implementation with respect to domestic and international standards or requirements.
Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.
Have an understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems.
We offer you
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have affected billions of lives. Your ideas and ability to deliver will help to transform the future of healthcare and allow you to create your own legacy.
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.