CAPA Engineer

CAPA Engineer (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:

Support Philips quality initiatives and CAPA programs as a CAPA Engineer within Monitoring Analytics.   

You will be responsible for:

Coordinates project planning on key corporate CAPA programs. 

Works with subject matter experts to develop plans and execute corrective action activities to resolve audit findings. 

Leads teams in using problem solving tools and sound statistical analysis to find root causes of product and process issues to meet regulatory requirements and process improvement goals. 

Effectively apply quality engineering knowledge and project management expertise to support initiatives and solve business problems, assist with data analysis and report preparation for all required data submissions. 

Tracks and reports weekly during project reviews on status, successes, issues and slippage; budget and spending status if appropriate; next steps in the project effort to complete needed tasks along with other key project metrics 

Resource Management, Determine roles of cross-functional team members based on project requirements, timeframes and budget. 

Manages multiple project teams and resources towards project successes. Defined skill sets (competencies) required for team members based on project specifications and requirements, Creates or participates in the creation of, project documentation. I.e. scope documents, budgets, timelines, checklists, status reports, etc. evaluates key deliverables and final product to ensure traceability of requirements, high quality and acceptance, communicates progress, risks, expectations, timelines, milestones and other key project metrics to clients and team members. Coordinate meetings, Ensure Project Plans stay on target, Stay on top of Philips employees and make sure they are on task, Coordinate activities and make sure dates are correct.

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

•Minimum 8 years professional experience in the applicable role. 

•Bachelor's /Master's degree in Engineering. Demonstrated capability and experience in role.

•Understanding and application of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, and others including familiarity with the European Medical Device Regulation MDR 2017/745.

•Experienced Engineer with proven success within teams and delivering on organizational objectives

•Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.

•Advanced Analytical Skills; demonstrated ability to troubleshoot complex process/system issues

•Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management

•Strong communication skills; ability to prioritize and manage multiple simultaneous programs/projects

•Strong IT Skills

You will be a part of:

You are empowered to use your voice and expertise to have a positive impact on your team, the business, and health technologies that will improve the health, well-being and care for people around 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.