Medical Device Correction Specialist
1 maand geleden
Job Title
Principal Correction and Removal Specialist
Job Description
Program Manager, Correction and Removals
In this role, you will have the opportunity to contribute to the future of healthcare technology by ensuring the successful management of the Correction and Removal (C&R) process. You will lead end-to-end (E2E) field actions, collaborating with cross-functional teams to deliver solutions that meet both regulatory requirements and customer needs.
Your role:
- Oversee the complete correction and removal process to ensure effective, compliant, and timely field action execution.
- Work closely with cross-functional teams including complaint handling, investigation committees, engineering, regulatory bodies, and field deployment to coordinate activities.
- Lead the coordination of recall responses, documentation, and regulatory submissions, ensuring compliance and alignment with risk assessments.
- Collaborate with key stakeholders, including medical and quality leaders, to ensure the quality and effectiveness of all field actions and the continuous improvement of internal processes.
- Provide valuable feedback from the field to engineering and development teams to enhance product quality and reduce future corrective actions.
You're the right fit if:
- You have acquired 5-7 years of broad experience in Quality Management and/or Post Market Surveillance experience. You also have experience supporting post-market risk assessments, recall decisions and execution supporting audits, and proven ability to work independently.
- Your skills include experience collaborating with local stakeholders for the proper adaptation of quality system processes and driving common Quality & Regulatory goals and objectives towards improved customer experience, patient safety and quality, operational excellence & dedicated regulatory compliance.
- You have an in-depth knowledge of relevant medical device industry standards ISO 13485. Experienced with Corrective and Preventive Actions (CAPAs) and Recalls in a medical device setting. Bachelor's degree in a relevant scientific or engineering field or higher is preferred; Project Management experience is also preferred. Will consider candidates with equivalent relevant experience and education.
- You have an ability to influence without expressed authority, have a strong accountability for results achieved, and a strong passion for patient safety & quality.
- The ideal candidate will be viewed as an expert in Post Market Corrections and Removals as well as expertise in Project Management. A broad background in the Quality Management field as it pertains to the medical device industry.
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 .
Discover .
Learn more about .
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 .
#
-
Medical Device Corrective Action Specialist
4 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdJob Title:Principal Correction and Removal SpecialistJob Description:Program Manager, Correction and RemovalsIn this role, you will have the opportunity to contribute to the future of healthcare technology by ensuring the successful management of the Correction and Removal (C&R) process. You will lead end-to-end (E2E) field actions, collaborating with...
-
Medical Device Safety Compliance Specialist
2 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdAbout the RoleWe are seeking a Medical Device Safety Compliance Specialist to join our Quality LAB team.Job DescriptionAs a Medical Device Safety Compliance Specialist, you will be responsible for ensuring that Philips' Medical Devices meet the requirements of the latest international safety standards. You will execute objective and reproducible (IEC 60601)...
-
Senior Correction and Removal Process Manager
2 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdJob TitleSenior Correction and Removal Process ManagerJob DescriptionIn this role, you will contribute to the management of the Correction and Removal (C&R) process, collaborating with cross-functional teams to deliver solutions that meet regulatory requirements and customer needs.Your ResponsibilitiesOversee the complete correction and removal process to...
-
Complaint Handling Process Specialist
5 dagen geleden
Best, Noord-Brabant, Nederland Philips VoltijdAbout the Role:We are seeking a skilled Complaint Handling Process Specialist to join our Clinical Informatics team at Philips. As a key member of this team, you will play a crucial role in ensuring patient safety and quality, customer satisfaction, and regulatory compliance through the complaint-handling process.Key Responsibilities:Ensure timeliness and...
-
Complaint Handling Process Specialist
2 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdAbout the Role We are seeking a skilled Complaint Handling Business Process Expert to join our Clinical Informatics team. This role is responsible for ensuring timeliness and high quality of complaint investigations in the End-to-end complaint handling process. The successful candidate will work closely with the BU lead to support complaint handling strategy...
-
Reliability Engineer
2 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdAbout This RoleWe are seeking a skilled Reliability Engineer to join our team at Philips. As a key member of our organization, you will be responsible for ensuring the quality and reliability of our medical devices.
-
Safety Test Engineer
3 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdJob TitleSafety Test Engineer for Medical DevicesAbout the RoleYou will be responsible for executing objective and reproducible safety compliance tests for medical devices as part of Philips' Quality LAB.Your Key Responsibilities:Ensure medical devices comply with international safety standards.Set up, interpret, and report test results.Work closely with...
-
Senior Product Quality Assurance Specialist
4 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdAbout the RoleWe are seeking a highly skilled Senior Product Quality Assurance Specialist to join our team at Philips. As a key member of our organization, you will be responsible for ensuring the quality and reliability of our medical devices.Key ResponsibilitiesDevelop and implement quality and reliability strategies for our productsCollaborate with...
-
Design Quality Assurance Specialist
4 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdAbout the Role:We are seeking a highly skilled Design Quality Assurance Specialist to join our team at Philips. As a key member of our Patient Safety and Quality organization, you will play a critical role in ensuring the design quality of our medical devices.Key Responsibilities:Provide independent oversight of the design input process, design V&V...
-
Product Coordinator
4 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdJob Title:Product Hold CoordinatorJob Description:As a Product Hold Coordinator at Philips, you will play a crucial role in ensuring the timely segregation and disposition of non-conforming products. This is a critical function that requires close collaboration with cross-functional teams to guarantee patient safety and product quality.Your Role:- Manage the...
-
Senior C++ Software Engineer
3 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdJob Title: Senior C++ Software EngineerJob Description:We are seeking a skilled Senior C++ Software Engineer to join our team and contribute to the development of our intravascular imaging and functional measurement application software suite. As a key member of our team, you will be responsible for designing and implementing high-quality software solutions...
-
Senior Technical Test Specialist
3 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdRole OverviewYou will be responsible for executing objective and reproducible safety compliance tests as part of the Quality LAB at Philips. This involves setting up tests, interpreting results, and preparing test reports to ensure that our medical devices meet international safety standards.Your Key Responsibilities:* Execute safety compliance tests in...
-
Risk Management Systems Engineer
3 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdJob Title: Senior Systems EngineerJob Description:We are seeking an experienced Senior Systems Engineer to join our team at Philips. In this role, you will be responsible for leading product safety risk management activities related to our Azurion and Allura IGT platforms.Your Role:Support in the execution of product safety risk management activitiesActively...
-
Senior Systems Engineer
3 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdAbout the Role:As a Senior Systems Engineer at Philips, you will be responsible for ensuring the safety and reliability of our Image Guided Therapy systems. This includes supporting new product introductions, post-market surveillance, and maintenance initiatives. You will work closely with cross-functional teams to drive safety risk assessment and risk...
-
Senior Safety Test Engineer
4 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdJob TitleSafety Compliance SpecialistAt Philips, we are committed to ensuring the safety of our products, patients, and healthcare workers worldwide. As a Safety Compliance Specialist, you will play a crucial role in this effort.Your Role:Ensure that Philips' Medical Devices meet the requirements of the latest international safety standards.Plan and perform...
-
Best, Noord-Brabant, Nederland Philips VoltijdAbout PhilipsWe are a health technology company driven by the belief that every human matters.Job DescriptionAs a Senior C++ Software Engineer, you will play a pivotal role in developing sophisticated application software for our intravascular imaging and functional measurement application software suite. This challenging position involves working on the...
-
Packaging Specialist with Medical Products
2 weken geleden
Best, Noord-Brabant, Nederland Olympia VoltijdCompany OverviewRhenus Logistics, located in Best, offers an informal work environment with numerous opportunities for growth. The location is easily accessible from Eindhoven, Tilburg, and 's Hertogenbosch, providing a pleasant working atmosphere.This logistics center serves one of the largest customers, handling medical machines delivered to hospitals....
-
Senior Safety Test Engineer
4 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdJob OverviewSenior Safety Test Engineers form a critical part of Philips' Quality LAB, responsible for ensuring the company's medical devices meet the latest international safety standards. This role plays a pivotal role in safeguarding the safety of patients, healthcare workers, and products worldwide.Develop and execute IEC 60601-compliant safety testing...
-
Program Director
4 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdJob TitleProgram Manager - Design for ExcellenceJob DescriptionAt Philips, we're committed to delivering exceptional value to our customers through innovative design solutions. As a Program Manager - Design for Excellence, you'll play a key role in driving business growth and profitability by identifying and implementing cost-saving initiatives.Your...
-
Senior Safety Test Engineer
2 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdJob TitleSafety Compliance Testing for Medical DevicesYour RoleExecute IEC 60601 safety compliance tests for Philips' Medical Devices to ensure compliance with international safety standards.Plan, perform, and analyze tests on hardware and software of medical devices, interpreting results and preparing test reports for product certification.Set up, test,...
