Job Title

Job Description

Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*. Employees may request a reasonable accommodation. *Montana employees are currently excluded from this requirement at this time.

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.

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better

Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

The Quality Engineer promotes and implements organizational policies & standards to ensure product quality from design transfer to warehouse and distribution, including postponement/late customization, in compliance with regulatory requirements and Philips' Business Systems/procedures

You are responsible for

• Ensure compliance with the Quality Management System, in accordance with Philips Policies and applicable worldwide regulations and standards.
• Facilitate development of and sustaining activities in support of core supply chain quality functions including nonconforming material management, acceptance activities, and general quality system functions for warehousing, distribution, manufacturing, and merge activities.
• Provide quality support to Integrated Warehousing and Distribution functions.
• Support and Review where applicable Process Development, Validation, and Quality Controls throughout the lifecycle of supply chain products/solutions ensuring all necessary documents/records are maintained throughout the lifecycle of the product/solution.
• Partner with Supplier Quality on processes related to the acquisition of purchased services, solutions, materials, components, sub-assemblies, and completed products and to ensure vendor assessments are completed
• Lead and/or influence Productivity Programs and Critical process changes
• Assist in the development and monitoring of QA and Supply Chain metrics.
• Accountable for implementing and improving Supply Chain Quality Engineering capabilities supporting the supply chain.
• Responsible for leading quality assurance activities, such as:
  • Responsible to ensure Supply Chain quality systems are maintained and documented.
  • Participates and supports the completion of NPI and Product transfers in the supply chain locations.
  • Reports on project timelines and tracking of product transfers.
  • Reviews and approves quality documentation and records, and responsible for generation where applicable.
  • Analyzes data for reports and validation activities as well as process improvement initiatives.
  • Responsible for timely review and approval of nonconforming records for nonconforming material within the warehouse and determining or partnering with business to determine appropriate product disposition.
  • Assists with delivery hold execution and leads some hold activities.
• Responsible for Non Conformance Management (Root Cause Analysis, Corrections, Corrective and Preventive Actions) in accordance with required timelines.
• Accountable for ensuring timely review and approval of nonconforming records for nonconforming material within the warehouse and facilitating appropriate product dispositions partnering with business where necessary.
• Responsible to meet departmental metrics.
• Drive lean initiatives, continuous improvement and complete QEKs, VSMs.
• Provide Q&R oversight on Operations projects ensuring timely completion and appropriate quality of project deliverables.

To succeed in this role, you’ll need a customer-first attitude and the following

• 3+ years of related engineering experience (medical device or regulated industry preferred).

• Knowledge of Supply Chain operations related to warehouse, distribution, and manufacturing and quality system requirements.

• Frequently interacts with subordinate supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.

• Wide-ranging experience within an engineering function.

• Well versed in Quality Engineering and Continuous Improvement techniques.

• Direct working relationships with suppliers preferred.

• Participated in several NPIs from start to finish.

• Prior experience in working in a manufacturing or warehouse related environment preferred.

• Ability to manage competing priorities in a fast-paced environment.

• Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), EU MDR, Japanese MHLW Ordinance 169, and ISO 9001.

Technical background:

• Bachelor degree in Engineering Science, or equivalent experience with 3+ years of experience in a medical device or regulated industry.

• Knowledge of Supply Chain operations related to warehouse, distribution, and manufacturing and quality system requirements.

• Frequently interacts with supervisors, managers and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.

• Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.

• Follows processes and operational policies in selecting methods and techniques for obtaining solutions

• Often must lead a cooperative effort among members of a project team.

• Strong knowledge of Design Transfer, Acceptance Activities, Production and Process Controls, and Supplier Quality Design Transfer activities.

• Excellent technical, writing and communication skills and interpersonal relationship skills including negotiating and relationship management skills.

• Identifies technical and process gaps and takes action to address them.

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa. Relentless focus on Product Quality as an organizational value.

In return, we offer you

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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Visit our careers website to explore what it’s like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some frequently asked questions.

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Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.