QA Engineer

QA Engineer II (Randstad Contingent Worker)

This is a fully remote position that can be based anywhere in the U.S. 

In this role, you will have the opportunity to:

Maintains a compliant, lean and effective MS/QMS. Partners across the business to continually improve and standardize PD's MS/QMS structure, documents and systems. Monitors, measures, and drives in-scope functional & process performance (both on-going and strategic). You will report directly to the Quality Management Systems Manager Precision Diagnosis North America.

You will be responsible for:

• Ensures external and internal audit readiness and provides support during external and internal

audits.

• Reviews QMS and Engineering changes as well as Quality plans to ensure compliance/conformance to FDA regulations and other Regulatory Agency and consensus

standard requirements.

• Ensures adequate service levels and quality for document control, records management,

software validation, CAPA, Quality Planning, Management Review, QMS processes; monitoring

and assurance of process performance.

• Represents QMS/Engineering Change processes and records to regulatory agencies as required.

• Owns QMS CAPAs, develops adequate and defensible root cause analyses and action plans;

completes plans to schedule.

• Actively assists in managing a program of CAPAs; accountable for timely and comprehensive

corrective and preventive management of issues/opportunities.

• Actively assists in managing a program of Quality Plans; accountable for plan accuracy and onschedule plan closure.

• Proactively identifies areas of emerging risk and advises on directions for future areas of

analysis/development.

• Acts as QMS competence expert, coaching and developing skills and knowledge within the QMS team.

• Supports the move toward the Philips Excellence Process Framework for the transformation the

business to the Philips Business System including the Philips Integrated IT Landscape.

• Promoting Q&R awareness level as determined within the organization.

• Managing the enforcement of standardized quality systems across the Business; ensuring

deployment of strategic projects & E2E PIL Solutions to schedule.

• Establishes an effective Management Review process, including routine reporting.

• Managing the strategic improvement processes (‘breakthrough Program’) in the Business (One

Page Strategy, Hoshin Plan).

• Participates in Quality & Regulatory initiatives as a cross functional contributor.

• Creates PQMS transformation awareness and establishes the Philips Business System, manages all activities under the PQMS governance.

• Establishes operational objectives and work plans, and delegates assignments to subordinates.

• Establishes and assures adherence to schedules, work plans and performance requirements.

• May manage or oversee individual contributors. You are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around the world.

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

•Bachelor’s degree plus a minimum of 2 years of related experience in the medical device or other 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

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.