Senior Quality Compliance Manager
vor 4 Wochen
Job Title
Senior Quality Compliance Manager (m/f/d)
Job Description
As the Senior Quality Compliance Manager at HPM Boblingen Site, you'll spearhead the cultivation of a patient safety and quality-oriented culture, ensuring end-to-end compliance with quality management systems (QMS). Reporting directly to the HPM Director of Quality Compliance, you will manage internal audits, drive improvements in quality subsystems, and provide crucial guidance during external audits.
Your Role:
Ownership and oversight of the CAPA, NCR and Internal audit programs specific to the Boblingen site.
Provide guidance to end users on how to correctly execute compliance processes (i.e. CAPA, NCR/QN, Audit Finding resolution, Quality Planning, etc..).
Drive cultural transformation towards patient safety and quality by identifying and sharing “Best Practices”..
Ensure timely responses to audit non-conformances, maintaining adherence to agreed-upon timelines and fostering accountability.
Identify and promote best practices within the organization, enhancing compliance standards and fostering continuous improvement.
Provide support for external audit readiness and during external audits, act as SME for owned processes.
Identify compliance support needs through monitoring actions and assessment of compliance data, actively addressing deficiencies.
Participate as a cross-functional contributor in Quality & Regulatory initiatives, leveraging expertise to drive compliance enhancements and operational excellence.
You're the Right Fit if:
You have at least 6 years of related experience in the medical device, IVD, biologics, or pharmaceutical industry.
You have held a leadership role either directly or as part of a matrix organization.
Your expertise includes a practical understanding of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.
You have clear and effective communication skills, both verbal and written, and excellent interpersonal & time-management skills.
Viewed as an expert in the field and have a solid grasp of CAPA, NCR/QN and Internal Audit processes.
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.
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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 .
Please note that all applications must be submitted in English.
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