CAPA Quality Engineer

Note: This position will be onsite and the role will potentially support activities across the following Philips facilities: New Kensington, Murrysville, Bakery Square, Mt. Pleasant.

In this role, you will have the opportunity to:

Responsible for driving CAPA activities from issue identification to closure, effectively project managing all CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board meetings.

You will be responsible for:

• Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.

• Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.

• Represent CAPAs during audits and CAPA Review Board meetings.

• Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).

• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.

• Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.

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

•Bachelor’s degree plus a minimum of 5 years, or a Master’s degree plus a minimum of 3 years of related experience, in the medical device or another regulated industry and in the application of automated technology, particularly GAMP 5

•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

•Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations

•An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization

•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

•Ability to travel up to 25%

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. You will report directly to the Head of Philips Quality Management Systems & Compliance.

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.