QMS Internal Auditor
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:
Assure international regulatory and legal compliance of the Philips quality system(s) and company-wide compliance with Philips quality policies, quality objectives, and quality standards. Responsible to perform timely, detailed, and independent internal quality management system (QMS), product-focused, and/or clinical audits to assess regulatory compliance to applicable local and international regulations/standards and Philips requirements.
You will be responsible for:
• Plan, coordinate, and execute internal QMS and/or product-focused audits to assess the compliance and effectiveness of the overall QMS of the organizational unit(s) under audit.
• Plan, coordinate, and execute clinical audits to assess clinical study compliance with Good Clinical Practice (GCP), regulatory standards, and study procedures.
• Review responses to audit findings for completeness and effectiveness.
• Provide compliance support including:
o review of responses to audit findings for completeness and effectiveness
o coaching new auditors
o data analysis and program support for the Audit Program Lead
o participation in Quality initiatives as a cross functional contributor
To succeed in this role, you should have the following skills and experience:
•Bachelor’s degree, or equivalent experience
•6+ years’ experience in a regulated industry (medical device, IVD, biologics, or Pharma for medical audit programs)
• Expert knowledge of global governing regulations, requirements, and standards such as 21CFR Parts 803, 806, 820, 11; ISO 13485, ISO 9001, ISO 14971, European Medical Devices Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169.
• Expert CAPA Knowledge and experience.
•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.