Solution Architect NL (fluent Dutch)

Work location: NewCompliance Head Quarters in The Hague, NL

NewCompliance “Driving Value in healthcare”

Become part of our growing community of bright, motivated people who are dedicated and inspired by what they do best. Over the last 15 years, NewCompliance has grown into a successful brand and global leader in the actionable medical information industry, running in more than 35 health systems in Europe and the United States. We work together with reputable partners such as Stryker, Philips, and Medtronic empowering them with our technological solutions.

At NewCompliance, we are passionate about enabling healthcare professionals to deliver the highest quality patient care possible. We are a team of experienced professionals who have first-hand experience building and scaling digital health solutions within the healthcare IT space. We are passionate about what we do and believe in our vision to improve the quality of care and reduce costs and process waste.

We are NewCompliance. Join us if you care to make a difference in healthcare.

Job Summary

At NewCompliance, we are passionate about enabling healthcare professionals to deliver the highest quality patient care possible. We are looking for a proactive Solution Architect, who loves putting exciting technologies to work in order to help solve healthcare challenges. A talented and driven technologist, who will bring vision to the collaboration with our customers and their IT teams, in order to manage and deliver the implementation of our platform and services in a smooth, consistent manner. You will play a key role in implementation of our rapidly growing national portfolio.

The role is responsible for working closely with our customers and local distributors, in support of establishing system integrations and interfaces (HL7, API, GBS/ BMS) with hospital software applications (EMR, hospital equipment, IoT). You’ll serve as a facilitator, systems analyst, liaison and coach utilizing your expertise to assure success and stability in our project implementation results.

Primary responsibilities

• Engage directly with customers to discuss requirements, design, and develop ways to integrate their EMR/EHR and buildings with the NewCompliance solutions and turning those requirements into technical specifications.
• Install and configure customer environments (i.e. acceptance and production).
• Participate and work closely with the Development Team to continuously improve our software and automated test- deployment practices.
• Consult with internal IT colleagues, subject matter experts and other team members to determine data extraction and transformation requirements.
• Drive Interface Requirements Definitions and Inbound/Outbound message mapping specifications. Coordinate the setup of secure data transfer mechanisms between EMRs, building management systems and/or PMS.
• Understand the relevant compliance issues and IT requirements and advise on product and integration decisions to ensure proper compliance and customer success.
• Provide coordination and support for user acceptance testing (planning, organizing, execution and support).
• Understand the relevant compliance issues and IT requirements and advise on product and integration decisions to ensure proper compliance and customer success.
• est. 10 – 20% travel may be required (occasional visit to project sites, on-site team training or support, field events, customer implementations/go-live).

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or Computer Science (or related field).
• 2 – 4 years’ of professional work experience.
• Familiar with working in Agile/ Scrum environments.
• In depth knowledge and experience with IT integrations.
• Experience with EMRs and EHRs is a big advantage.
• Basic understanding of digital (healthcare) issues and developments: major EHR vendors, Interoperability, HL7, FHIR, Modbus/ BACnet.
• Experience with data transformation and mapping / configuring interfacing types such as: ADT, ORU, SIU, XML.
• Outstanding analytical and problem-solving aptitude. Proven self-motivator.
• Dutch is your mother tongue and you have Business Level English.
• Excellent communication and customer service and people skills: ability to document and explain solution elements, to both management and clinical staff.
• Enthusiastic and hands-on attitude. Creative in finding solutions combining processes, systems and people. Focused on finding solutions.

 

Preferred Qualifications

• Experience working with enterprise and/or cloud (healthcare) software.
• Experience working with SQL, HL7 2.x, FHIR and/or using integration engines such as Mirth, Cloverleaf, Ensemble etc. is a big plus but not essential.
• Able to build bridges between technical and non-technical stakeholders.

Compensation

NewCompliance offers a highly inspiring, talented, high-learning, and go-getting environment where you will enjoy a lot of freedom and comradery to do your work well and make our customers happy. We are a close-knit group of young professionals that are deeply motivated to work on creating breakthroughs in the quality of critical care provided around the globe.

We offer nice and flexible working conditions: working from home, lunch is catered & fruit is available daily in the office, 25 days of vacation leave and a competitive pay and benefits package.

Apply?

Please send your application with CV through LinkedIn or directly to me: Siona van Dijk, s.vandijk@newcompliance.com.

Please feel free to contact me if you need any further information: 06 – 29 36 33 67.

NewCompliance is ISO 27001 & ISO 13485 certified, which means that NewCompliance works according to standard procedures to improve our service and to bring safe products to the market.

 

Acquisition regarding vacancies is not appreciated

Quality Assurance Manager NL

Work location: NewCompliance Head Quarters in The Hague, NL

NewCompliance “Driving value in healthcare”

Become part of our growing community of bright, motivated people who are dedicated and inspired by what they do best. Over the last 15 years, NewCompliance has grown into a successful brand and global leader in the actionable medical information industry, running in more than 35 health systems in Europe and the United States. We work together with reputable partners such as Stryker, Philips, and Medtronic empowering them with our technological solutions.

At NewCompliance, we are passionate about enabling healthcare professionals to deliver the highest quality patient care possible. We are a team of experienced professionals who have first-hand experience building and scaling digital health solutions within the healthcare IT space. We are passionate about what we do and believe in our vision to improve the quality of care and reduce costs and process waste.

We are NewCompliance. Join us if you care to make a difference in healthcare.

Job Summary

As the Quality Assurance Manager, you will take a leading role in maintaining and reviewing the ISO13485:2016 Quality Management System (QMS), and in the future Medical Device Regulation (MDR), for the design, development and release of our medical software applications. Together with the Management Team and Team-Heads, you will define the strategy, timelines and required steps to continually ensure regulatory compliance and certification of NewCompliance. You will manage the certification pathway and ensure that NewCompliance is ready for audits by the Notified Body and maintain relations with all stakeholders. You will provide the team with training, tools and guidance for Design Control and Document Control to ensure processes are in place and adhered to and necessary documentation for regulatory submissions is established. You will schedule, prepare and lead all internal and external audits of the organization, including the audits by the Notified Body.

Responsibilities

• Lead and maintain the Quality Management System within the organization, in conformance with ISO 13485:2016 and Medical Device Regulation (MDR)
• Establish a Design History File and Technical Dossier for regulatory submission(s)
• Communication with regulatory authorities and specifically the Notified Body for audit(s)
• Ensure implementation of Document Controls with a supporting role for document control in the product development process
• Ensure implementation of Design Controls for the medical device (software) development, verification and validation processes
• Ensure implementation of Complaint Handling, CAPA, Vigilance and PMS processes
• Ensure adequate competence and training of personnel, including coordination, administration and evaluation
• Lead Review & Approval activities; this includes design verification and validation documentation
• Lead Inspection & Acceptance activities; this includes acceptance of supplier deliverables
• Lead Management Review activities; this includes measuring and analysis of Key Performance Indicators for product and process improvement

Qualifications

• A Bachelor’s or master’s degree (HBO/WO) in Management or related field
• At least 3 years of full-time work experience with setting up and maintaining an ISO 13485 Quality Management System/ Medical Device Regulation (MDR)
• Demonstrable experience in writing Quality Policies and Procedures and composing Technical Dossiers suitable for regulatory submissions
• Strong familiarity with the Medical Device Directive (MDD) and/or Regulation (MDR), including experience with the CE Certification (or FDA approval) process of a Medical Device
• Prior experience with Notified Body and/or FDA audits is preferred
• Prior experience with standards for Risk Management (ISO 14971) and Medical Device Software (IEC 62304) is an advantage
• Excellent interpersonal skills with ability to communicate and collaborate with all levels within the company
• Ability to work independently as well as part of a team
• Strong communication and reporting skills, in Dutch and English, both verbally and in writing
• Strong analytical skills and ability to assimilate, articulate and present information
• Energetic personality with an active stance and pro-active approach
• Eye for detail, pragmatic and result-oriented

Compensation

NewCompliance offers a highly inspiring, talented, high-learning, and go-getting environment where you will enjoy a lot of freedom and comradery to do your work well and make our customers happy. We are a close-knit group of young professionals that are deeply motivated to work on creating breakthroughs in the quality of critical care provided around the globe.

We offer nice and flexible working conditions: working from home, lunch is catered & fruit is available daily in the office, 25 days of vacation leave and a competitive pay and benefits package.

Apply?

Please send your application with CV through LinkedIn or directly to me: Siona van Dijk, s.vandijk@newcompliance.com.

Please feel free to contact me if you need any further information: 06 – 29 36 33 67.

NewCompliance is ISO 27001 & ISO 13485 certified, which means that NewCompliance works according to standard procedures to improve our service and to bring safe products to the market.

Acquisition regarding vacancies is not appreciated