QA Engineer

QA Engineer (Randstad Contingent Worker)

Actual Job Title: Q&R Project Quality Assurance Specialist

This position is available for a fully remote schedule to anyone home-based in the United States.

In this role, you will have the opportunity to:

The QMS Manager 60 (Project Quality Assurance Specialist) works to ensure that the quality processes, tools and methods used within the Philips Global Quality Program Portfolio Office projects/programs are performed in compliance with the company’s Quality Management System (QMS) requirements and local GQ PMO processes. Under general direction of the QMS Program Direction (Quality Representative), the role is responsible for creation of controlled documents and managing all document control activities for the GQ PMO Quality System, working/collaborating with project/program managers to provide orientation and to perform project/program quality assurance reviews, managing training assignments to employees and the creation and delivery of training and learning course materials, as well as supporting a variety of quality projects and initiatives.

You will be responsible for:

• Per direction from QMS Program Director (QA), work with Project Managers to ensure that quality oversight activities within projects are started at the right time, respected throughout the project lifecycle and driven until a successful launch of the project.
• Within scope of audits and project reviews, proactively identify issues and find appropriate contacts/assistance/answers; then work with the QMS Program Director (QA) to apply solutions, or escalate as necessary.
• Support the execution of the PMO's quality assurance infrastructure routines according to the Philips Quality Management System and accepted rules and standards
• Execute reviews and approvals at appropriate Quality Gate stages, as assigned
• Partner with Project Quality Assurance Manager to intervene as appropriate, if any activity is perceived to have a negative impact on project execution within Quality guidelines
• Participate in continuous improvement project teams, determine effectiveness of improvement activities and applicability to own a team.
• Performs timely, detailed, and independent internal Quality Management System (QMS), project-focused audits to assess regulatory compliance to applicable local and international regulations/standards and Philips requirements.

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

• 3+ years of related experience in a medical device, IVD, biologics or Pharma industry.
• 3+ years in management of and working knowledge of the creation of Procedures and Work Instructions and management of Document Control activities appropriate for compliance with global medical device regulations, requirements, and standards
• 3+ years working as a Quality Assurance Reviewer or Auditor for Projects or Programs or similar work experience (e.g., CQA, Project Administration, Project Management Certification, or professional training, etc.)
• 3+ years working with development and delivery of training/learning materials, and managing employee training assignments.
• Strong ability to manage all work responsibilities remotely, with teams located in various sites and/or countries.
• Expert knowledge working with MS Office Suite (Excel, PPT, MS Word, PPT, etc.); SharePoint, MS Teams. In addition, experience working with Smartsheet is preferred however not required.
• A bachelor’s degree in business administration, engineering, supply chain operations, Quality Management or a related field. Comparable business experience to a bachelor’s degree will also be considered for exceptional candidates, at hiring manager’s discretion.
• Familiarity with Quality Management Systems (QMS), Good Documentation Practices, Medical Device Manufacturing
• Works independently and as part of a team to analyze, report, and deliver data regarding various aspects of quality assurance and Key Performance Indicators.
• Situational Thinking: Maintain flexibility in thinking through challenges, making decisions and solving problems in a variety of situations (e.g. analytical, creative, logical and systems thinking, implicative, strategic).
• Ongoing Passion for Learning: Constantly develop and renew leadership and technical skill set for yourself as well as those on the team
• Ability to effectively communicate detailed information and strategic decisions, and respond to questions from project stakeholders of all levels, including C-Suite Members

You will be a part of:

An organization that believes what you do every day can contribute to the innovative health technologies and solutions we develop that make a positive impact on billions of people every year. Including you. Because you will find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It is our mission to improve people’s lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.

In return, we offer you:

Philips welcomes you to a challenging, innovative environment with great opportunities for you to explore and grow.

Quality is on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, groundbreaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role you will have an array of diverse career opportunities open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.

Why work on a project at Philips?

If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.