Sr. Quality Systems Engineer

08 Oct 2024

Vacancy expired!

Job Title Sr. Quality Systems Engineer

Job Description 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 post market activities and other quality tasks for the Sleep & Respiratory Care business unit with primary responsibilities in ensuring compliance in a fast-paced, changing global regulatory environment. The role includes development of strategies to act proactively where appropriate and reactively where necessary based on product performance in the field. The Sr. Quality Systems Engineer interfaces with all elements of the quality management system, Sleep & Respiratory Care business, global Philips businesses and markets, regulators, and notified bodies.

The post-market surveillance team is responsible for monitoring, investigating, tracking and reporting on the performance of all Sleep & Respiratory Care products in the field. This activity is undertaken primarily through the management of the Complaint Handling System. The team is responsible for global vigilance reporting of individual events, field actions, communications with regulatory authorities and notified bodies, and creating the data required to make key decisions at the executive level to drive business critical decisions.

You are responsible for
  • Complaint Handling in accordance with global regulations and standards
  • Manage device field action and correction
  • Drive the identification and investigation of critical product issues based on field data
  • Design and implement compliant regulatory solutions supporting new paths to market
  • Support post market activities related to new product introduction

Primary Responsibilities
  • Team with a variety of roles such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate post market surveillance processes globally
  • Provide primary quality engineering support for global post market surveillance processes including complaint handling, vigilance reporting, field action, and post market surveillance planning activities
  • Drive technical product investigations in support of field complaints, regulatory agency inquiries, CAPA, service actions, or other objectives and translate results for use in the quality management system.
  • Consistently apply established device Risk Management File (RMF) decisions to investigations for both individual device failures and systemic failure modes. Identify and escalate issues not represented in established RMF.
  • Ensure continued alignment of RMF with strategy for global vigilance reporting
  • Coordinate development of strategy and implementation of field actions including risk assessment and plans for global vigilance reporting
  • Drive execution of field actions on a global scale with responsibility to identify, assess, and overcome barriers to correction, keep current records, provide periodic status updates, and close field actions
  • Team with Design Quality Engineering to ensure post market surveillance process capability is established for new product introductions
  • Evaluate and apply regulatory guidance and changes to post market surveillance processes to ensure continued regulatory compliance
  • Create responses to regulatory and customer inquiries
  • Facilitate Post Market Clinical Follow-up activities
  • Develop, implement, execute, and maintain post market surveillance plans for all products in partnership with Design Quality Engineering and Clinical Affairs
  • Provide support to Corrective and Preventive Action (CAPA) device investigations and corrections.
  • Support the internal audit program and participate in preparation and execution of internal and external audits of the local quality management system
  • Enable a culture of continuous improvement by identifying individual opportunities for improvement and delivering results using LEAN concepts
  • Lead continuous improvement projects driving cost savings and efficiency gains
  • Develop and share best practices locally and with other Philips business partners

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 interfaces with Philips Business Group and the leadership. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.

To succeed in this role, you should have the following skills and experience
  • Bachelor of Science in an engineering or applied science discipline
  • Minimum 5 years' experience in the medical device or other regulated industry
  • Demonstrated understanding of quality management system elements and interactions
  • Experience with process improvement, six-sigma, lean manufacturing, or equivalent
  • Experience with statistical analysis concepts and techniques
  • Demonstrated success in project management, teaming and influencing others to achieve results

Preferred Experience:
  • Strongly preferred - Familiarity in quality complaint handling, vigilance reporting, field action, risk management, and detailed product investigation
  • Applied knowledge and understanding of global medical device regulations
  • Experience working with electromechanical devices; medical devices supporting respiratory and pulmonary clinical applications
  • Experience teaming and interacting on a global scale

In return, we offer you

A path towards your most rewarding career. Philips is growing our manufacturing capability enterprise wide. Succeeding in this 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.

Our benefits can be found here: https://www.careers.philips.com/na/en/total-rewards-at-philips.

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.

Equal Employment and Opportunity Employer/Disabled/Veteran

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