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Philips Quality Engineer in Baltimore, Maryland

null If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance. In this role, you have the opportunity to support the realization and delivery of various products, key business improvement programs, and work with cross-functional teams from various geographical sites. You are responsible for

  • Verification of execution of processes and their deliverables in product creation and subcontracting projects and report the findings to upper management.

  • Review and Approval of designated project documentation in product creation projects.

  • Advice to product creation projects concerning the definition and implementation of quality assurance activities.

  • Advise upper management with respect to release for delivery of products.

  • Support and represent Q&R discipline in Design Reviews, Hazard Analysis brainstorms, Health Risk Assessments.

  • Initiate, stimulate, and support the implementation of process improvements.

  • Execution of audits in all business processes and report the findings to upper management.

  • Support and advise the organization in corrective and preventive actions.

  • Participate in the maintenance, improvement and deployment of the Quality Management System.

  • Translate regulations and standards and bring them to consolidation in the organization and the Quality Management System.

  • Represent the approbation officer in projects and support in the activities to acquire product licenses and approvals.

  • Participation in and verification off changes to DMR and release orders where Q&R involvement is needed.

  • Responsible for performing timely, SW Quality Engineering tasks: assessing software design and reviewing tests and other performance data, analyses market feedback, completing or assisting with in the root cause analysis and SW Quality problem solving

To succeed in this role, you should have the following skills and experience

  • Bachelor or Master degree in relevant knowledge domain

  • Minimum of 5+ years’ experience in Quality Engineering in an FDA regulated, ISO 13485 QMS, Medical software or systems, product environment

  • Experience managing and delivering CAPA’s, FMEA, Risk Management, Root Cause Analysis, Troubleshooting

  • Conduction Design Review under Design Controls

  • Competency working with requirements of FDA 21 CFR Part 820, ISO 13485, ISO 62304, ISO 14971, MDD, MDR and ISO 9001

  • Managing FDA Inspections and providing Internal and External Audit Support

  • Overseeing / Approving Design Verification/Validation plans, protocols, and reports

  • Working knowledge of appropriate global regulations, requirements, and standards

  • ASQ Certified Quality Engineer (CQE) or Six Sigma Green Belt / Black Belt

  • Knowledge of (software) processes and procedures

  • Good skills in reporting, both in writing and oral

  • Project management knowledge and skills.

  • Preferably knowledge of the basic functionality of our products

  • Knowledge of product creation and (software) development methods & tools

  • Experience in using problem solving tools

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 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 #LI-PH1 #LI-Remote