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Philips Senior Quality Engineer in United States of America - Home Based, Massachusetts

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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 c ontact 888-367-7223, option 5, for assistance.

In this role, you have the opportunity to

Develop and implement systems to ensure software as a medical device (SaMD) and services are designed and produced to meet or exceed customer and regulatory requirements-expectations. Establish the principles of product and service quality evaluation and control for the system.

You are responsible for

  • Provides quality engineering insight/ guidance on global compliance, such as CE Marking and product registrations, clinical evaluations, post market surveillance in accordance with FDA 21CFR, IEC62304, MDR, MDD, Canada Medical Device Regulations, etc.

  • Knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Legal Manufacturers, Notified Bodies, existing products in the EU regions, documentation and other aspects of medical device.

  • Develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.

  • Provides effective oversight to the execution of the Quality Plan, Risk Management activities and post market surveillance activities.

  • Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.

  • Have knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools, and reporting.

  • Understand a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.

  • Have experience of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.

  • Acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements.

  • Represents QMS/Engineering Change processes and records to regulatory agencies as required

  • Owns QMS CAPAs, develops adequate and defensible root cause analyses and action plans; completes plans to schedule

  • Actively assists in managing a program of CAPAs; accountable for timely and comprehensive corrective and preventive management of issues/opportunities

  • Actively assists in managing a program of Quality Plans; accountable for plan accuracy and on-schedule plan closure

  • Proactively identifies areas of emerging risk and advises on directions for future areas of analysis/development

  • Develop inspection and test strategies.

  • Reviews and assists in the development of verification and validation protocols and reports and identifies gaps for compliance with internal processes.

  • Author validation, verification, and inspection assessments to ensure the defensibility of product test data. Selects appropriate testing sample sizes based on criticality and statistical calculation.

  • Participates on teams to ensure robust application of appropriate design and manufacturing controls.

  • Supports leadership to ensure quality and completeness of project design history files, risk management files, validation packages, and change orders.

  • Provides ongoing quality engineering support throughout the software product lifecycle, including risk management, design and manufacturing changes, and CAPA investigations.

  • Engages in continuous improvement activities by identifying opportunities and recommending improvements to design and development process.

You are a part of

As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear works with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit.

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

  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

  • Strong working knowledge and application of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR 820, ISO 13485, IEC 62304, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, and others including familiarity with the European Medical Device Regulation MDR 2017/745.

  • Engineering Degree or equivalent experience in medical device industry.

  • At least 5 years’ experience in with Medical Devices.

  • ASQ certified Quality Engineer is a plus.

  • Understand risk analysis philosophies, methodologies, and their applications.

  • Have a working understanding of LEAN and six sigma concepts, methodologies and deployment.

  • An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization

  • Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.

  • Advanced Analytical Skills; demonstrated ability to troubleshoot complex process/system issues

  • Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management

  • Strong communication skills; ability to prioritize and manage multiple simultaneous programs/projects

  • Strong IT Skills

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.

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. Learn more by watching this video.

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.

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