Partners with applicable stakeholders to: ensure new/existing service offerings are developed in accordance to all regulatory/standard requirements, QMS is properly updated (as applicable) for new tools/systems and ensure all applicable documentation for required verification and validation is completed to ensure ongoing QMS compliance
Your role:
Partners with Service organization to ensure process to define, develop and deploy service offerings meet all applicable regulations and standards
Represents QMS/Engineering Change processes and records to regulatory agencies as required
As applicable, manage all the open Intra-company Quality agreements and Quality plans; accountable for ensuring plans are effectively monitored
Proactively identifies areas of emerging risk and advises on directions for future areas of analysis/development
Lead services and systems SW integration for successful onboarding and life-cycle management of SW applications.
Provide GxP-related quality assurance oversight, guidance, support and interpretation, with an emphasis on software validation, to personnel in their validation efforts, to ensure compliance; recommend appropriate corrective actions where needed.
Acts as QMS competence expert, coaching and developing skills and knowledge within the QMS team
Managing the QMS Document Control System, including the Philips Excellence Process Framework for the transformation the business to the Philips Business System in the Philips Integrated IT Landscape.
Promoting Q&R awareness level as determined within the organization, creates PQMS transformation and manages applicable activities under PQMS governance
Participates in Quality & Regulatory initiatives as a cross functional contributor
You're the right fit if:
14+ years experience in a similar role (Preferred medical device / Regulated industries)
Experience in Medical devices, Software Validation, ISO 13485, 21CFR 820, FDA Inspection, QMS Audit
BTech / MTech / BS /MS
Self-driven, Goal achiever, Individual with program management experience will help achieve required Goals
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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