In late January we announced that Bridgefield Capital signed an agreement to acquire Philips' Emergency Care business, which includes leading brands and products like HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions. We expect the transaction to close at the end of 2025. With Bridgefield's support and building on our 40+ year legacy of growth and innovation in emergency medical technology, the Emergency Care business will continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments.
The Manufacturing Quality Engineer is responsible for driving high-quality performance/monitoring, compliance, change-management, non-conformances, CAPA's and continuous quality improvement of manufacturing processes.
Your role:
Facilitate operations performance monitoring, reporting, improvement programs and development, in manufacturing and support analytical testing and Supplier Quality Engineering/Assurance (SQE/SQA) and purchasing.
Conducts assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design / process changes and assists in Manufacturing Process Development/Design Transfer activities.
Guides Material Review Board in the management of Non-conformances (NC) and Quality Notifications (QN) events including defect analysis, root cause(s) determination, proper disposition and implementation of effective Corrective and Preventive Actions (CAPA) actions.
Ensures manufacturing quality systems are maintained, handles single/complex process validation/improvement activities, and supports the completion of New Product Introduction (NPI)/product transfers.
Acts as an advisor / partner to meet schedules and/or solve technical problems, develops and administers schedules and performance requirements.
Cultivates effective relationships with internal/external partners and suppliers. Provides influence/support over projects, peer groups, and New Product Introductions (NPIs).
Provides input to validation protocols, facilitates production builds to support validation activities, analyzes data for reports, process improvement initiatives, and validation activities.
Utilizes advanced statistical analysis methods to interpret complex data trends, resolve a wide range of requests, and provide strategic insights for continuous enhancement of quality standards and process efficiency. Discusses detailed, strategic quality metrics and reports with stakeholders, highlighting significant achievements, emerging trends, and actionable insights to drive advanced improvement initiatives and ensure regulatory compliance.
Delivers specialized advanced training programs on cutting-edge quality standards, advanced methodologies, and best practices, fostering alignment across functions and advancing excellence in operational practices at an expert proficiency level.
You're the right fit if:
You've acquired a minimum of 5+ years' experience in FDA regulated/ISO 13485 QMS medical device quality/manufacturing environments with a focus on process quality, compliance, continuous improvement, non-conformance audit support, contract manufactruing, supplier assessmentetc.
You have proven experience in Data/Root Cause analysis, and technical/quality documentation.
You're able to build rapport and influence supervisors, functional peer groups and other internal customers/stakeholders.
You have detailed knowledge and experience in Process Engineering, Monitoring, Risk Assessment, and Design for Quality (DFQ)
You have a strong understanding of and experience in Regulatory Requirements, Compliance Management, Audit support and CAPA methodologies.
You have a minimum of a Bachelor's Degree in Engineering, Quality or related disciplines. ASQ or Six Sigma certifications desired.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
How we work together:
We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an Office role.
About Philips:
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
Learn more about our culture.
Philips Transparency Details:
The pay range for this position in Bothell, WA is $97,440 to $155,904.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.??
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information:
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bothell, WA.
May require travel up to 20%.
LI-PH1
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
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.
Equal Employment and Opportunity Employer/Disabled/Veteran
