Sonja Holten Email & Phone Number
@philips.com
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Who is Sonja Holten? Overview
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Sonja Holten is listed as Sr. Regulatory manager - Philips Personal Health - Grooming and Beauty - IPL at Philips, a company with 21 employees, based in Eindhoven, North Brabant, Netherlands. AeroLeads shows a work email signal at philips.com and a matched LinkedIn profile for Sonja Holten.
Sonja Holten previously worked as Regulatory Manager at Philips and Senior QA Consultant at Progressive Recruitment. Sonja Holten holds Msc, Electrochemistry from Utrecht University.
Email format at Philips
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AeroLeads found 1 current-domain work email signal for Sonja Holten. Compare company email patterns before reaching out.
About Sonja Holten
With a keen eye for improvement opportunities as well as being a talented organizer when things get tough, I like to take initiative and tend to find new paths. I have a knack for finding solutions where others got stuck. This has been of great value to the companies I thus far worked for. Besides being accomplished at my job, I always like to go the extra mile to be of added value to colleagues, customers and the company I work for. As a dedicated lifelong learner I like to rise to a challenge that requires the utmost of my intellect and my abilities.In the past I have worked on subjects in the following areas:• Supporting startups towards regulatory compliance by developing and using controlled quality processes• Regulatory strategies and compliance for medical devices, MDSW, non medical electrical and electronic equipment• Software test management• Complaint handling and CAPA management• Organizing people, workflows and tasks to meet external requirements and customer expectations.TechnicalQuality and quality management systemsITProject ManagementMedical device regulationRegulations on electrical equipment and installation products worldwide Certified/Trained/Experience in:• Process standards ISO 62304, ISO 13485, ISO 14971, ISO 14155, ISO 9001, ISO 62366• Electrical and Medical device product and compliance standards • Regulatory Supplier Management RAPS 2014• Auditing ISO 13485, ISO 9001• Adverse event and recall reporting, world wide• Internal/external auditing (on the job)• 8D, GMP, FMEA, SPC, Taguchi, LEAN ways of working.• Corrective and Preventive Action process (CAPA)• EU blue guide regulations, including MDR• FDA US Quality System Regulations (21CFR 803, 21CFR 806, 21CFR 807, 21CFR 820)• US federal product regulations (CDRH, FCC, OSHA and NFPA including NEC)• CCC, BIS, RCA, Denan and other world wide product regulations• Prince 2 Foundation• SQL• ISTQB• TMAP professional advanced• GC, HPLC, NMR, AAS, AES, SEM-EDX, ELISA• Statistical data analysisMy specialties: Share knowledge and work towards attainable solutions as a team in a pragmatic and logical way.
Listed skills include Quality System, Quality Assurance, Medical Devices, Iso 13485, and 21 others.
Sonja Holten's current company
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Sonja Holten work experience
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Regulatory Manager
CurrentRegulatory manager for Personal Health, grooming an beauty group. Together, with a dedicated SCR team of safety and compliance specialists, working to support the IPL development team on compliance aspects for the launch of the mostly medically regulated over the counter, intense pulsed light products, intended for hair removal at home. Ensuring the succes.
Senior Qa Consultant
CurrentSenior quality and regulatory consultant on secondment basis.
Senior Quality Assurance Engineer
Preparing for the recertification audit.
Regulatory Specialist
EU-MDR regulatory compliance of cloud based patient portal and e-health systems and solutions. Preparation and maintenance of medical device technical files and global submission documents for regulated products.
Q&R Support Engineer For Philips Ambient Experience
Parts and system compliance during the life cycle of ambience related solutions, installed next to and in combination with medical imaging and diagnostic devices in hospital rooms all over the world.Preparing for establishing an ISO 9001 management system and creating a landingspot for the organization within the already established Philips business.
Senior Quality Engineer For Philips Research
Guiding teams of researchers through innovation projects on general and specific quality and compliance related subjects for the creation of apps, algoritms and services. Also providing hands on support for compliant releases of non medical and medical devices, disposables or even prototype X-Ray machines. Prepare stacks of release documents for clinical.
Senior Qa Consultant
FDA preparation project. Auditing of recall execution, CAPA resolution and post market surveillance analysis for FDA Class 1 and IEC 62304 Class A and B medical software.
Quality Consultant
Consultancy position as subject matter expert on QA/RA subjects at Philips Medical Systems on the implementation project support team for the Global Philips Integrated Quality System.
Senior Qa Engineer
The company is in the final phase of developing and bringing to market a novel active implantable medical device, consisting of mechanical, electrical, semiconductor, hardware and software parts.The role of the QA engineer is for workflows and records, company wide, to remain or become sufficiently compliant for the certification of the company as well as.
Safety Manager For Quality & Regulatory, I-Xr
- Busines unit interventional X-Ray, Philips Healthcare develops, produces and delivers innovative and cutting edge X-Ray equipment intended for use in interventional medical procedures. The safety officers guide, help.
- product risk management
- post market surveillance, CAPA and world wide compliance
- communication with regulatory bodies and governmental agencies world wide
Test Analist
Analysis of test base, test design and test execution for several business critical projects
Project Manager
Sonja Holten education
Msc, Electrochemistry
Bachelor'S Degree, Hlo-Analytische Chemie
Frequently asked questions about Sonja Holten
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What company does Sonja Holten work for?
Sonja Holten works for Philips.
What is Sonja Holten's role at Philips?
Sonja Holten is listed as Sr. Regulatory manager - Philips Personal Health - Grooming and Beauty - IPL at Philips.
What is Sonja Holten's email address?
AeroLeads has found 1 work email signal at @philips.com for Sonja Holten at Philips.
Where is Sonja Holten based?
Sonja Holten is based in Eindhoven, North Brabant, Netherlands while working with Philips.
What companies has Sonja Holten worked for?
Sonja Holten has worked for Philips, Progressive Recruitment, Philips Vitalhealth, Sire | Life Sciences, and Sapiens Steering Brain Stimulation.
How can I contact Sonja Holten?
You can use AeroLeads to view verified contact signals for Sonja Holten at Philips, including work email, phone, and LinkedIn data when available.
What schools did Sonja Holten attend?
Sonja Holten holds Msc, Electrochemistry from Utrecht University.
What skills is Sonja Holten known for?
Sonja Holten is listed with skills including Quality System, Quality Assurance, Medical Devices, Iso 13485, Quality Management, Fda, Capa, and Process Improvement.
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