Quality Assurance Specialist

Q&R Project Quality Assurance Specialist (Randstad Contingent Worker)

This position will be fully remote and can be home-based from anywhere in the US.  

In this role, you will have the opportunity to:

The Global Quality Assurance Specialist works to secure that the quality processes, tools and methods used within the Philips Global Quality Program Management Office portfolio of projects are performed in compliance with the company’s Quality Management System (QMS) requirements. Under general direction of the Global Quality Project Quality Assurance Manager, the role is responsible for writing documentation, conducting quality audits and supporting a variety of quality projects and initiatives.

You will be responsible for:

- Per direction from the Sr. Manager of Project Quality Assurance, 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 quality assurance reviews, proactively identifies issues and find appropriate contacts/assistance/answers; works with the Sr. Manager of Project Quality Assurance to apply solutions or escalate as necessary.

- Support the execution of the Global Quality Portfolio Management Office (PMO) 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 Sr. Manager of Project Quality Assurance to intervene as appropriate, if any activity is perceived to have a negative impact on project execution within Quality guidelines.

- Participate in continuous improvement teams, determine effectiveness of improvement activities and applicability to own team.

- Performs timely, detailed, and independent internal project quality assurance reviews to assess compliance with Philips Project Standard Implementation Methodology (SIM), local processes and any applicable governance, regulation/standards and Philips requirements.

- Performs responsibilities of the Quality Assurance (QA) Document Control Specialist (QA DCS) for the administration of documents in the SharePoint libraries used for controlled organizational documents and coordinates documented training events in the Learning Management System.

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.

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

• Audit training/ experience (e.g., CQA or similar type training)

• Strong ability to manage projects remotely, with teams located in various sites and/or countries

• 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.

• Situational Thinking: Maintain flexibility in thinking through challenges, making decisions and solving problems in a variety of situations (e.g. analytical, creative, implicative, strategic)

• Ongoing Passion for Learning: Constantly develop and renew leadership and technical skillset 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.