CAPA Engineer

CAPA Engineer (Randstad Contingent Worker)

Actual Job Title: Quality Engineer PM Consultant I

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:

Drive CAPA activities from issue identification to closure, effectively manage all CAPA activities, and ensure the quality of CAPA record content. You will also represent CAPAs during audits and CAPA Review Board meetings.

You will be responsible for:

• Act as a Project Manager to drive CAPAs through closure with internal CAPA owners.
• Triage and root cause investigation of newly opened CAPA Requests.
• Work with Subject Matter Experts and Element Owners as needed to gather information and investigate issues.
• Gathering data from many systems for analysis.
• Triage completed investigations for CAPA Review Board.
• Independently produces and completes CAPA record.
• Ability to assess risk as it pertains to the CAPA.
• Responsible for performing timely, detailed CAPA engineering tasks like: assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.
• Represent CAPAs during audits and CAPA Review Board meetings.
• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
• Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.

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

• Bachelor’s degree in an engineering or scientific-related field or equivalent technical experience.
• At least 3 year of experience in Quality Engineering and CAPA processes.
• Able to understand and analyze complex problems, including software and hardware design issues.
• Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.
• Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.
• Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels.
• Strong Project Management skills, including ability to project manage all CAPA activities.
• Ability to analyze data and apply statistical techniques.
• Excellent written and verbal communication skills.

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.