EMEA Staff Quality Specialist Service & Repair, Orthopedics

 Bij Johnson & Johnson geloven we dat gezondheid alles is. Onze kracht op het gebied van innovatie in de gezondheidszorg stelt ons in staat een wereld op te bouwen waar complexe ziekten worden voorkomen, behandeld en genezen, waar behandelingen slimmer en minder invasief zijn en oplossingen persoonlijk zijn. Dankzij onze expertise op het gebied van innovatieve geneeskunde en MedTech bevinden we ons in een unieke positie om vandaag de dag te innoveren in het volledige spectrum van zorgoplossingen om de doorbraken van morgen te realiseren en een grote impact te hebben op de gezondheid van de mensheid. Ga voor meer informatie naar jnj.com

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Functie:

Quality

Subfunctie functie:

Customer/Commercial Quality

Functiecategorie:

People Leader

Alle vacaturelocaties:

Amersfoort, Utrecht, Netherlands

Functieomschrijving:Functieomschrijving:

We are looking for EMEA Staff Quality Specialist Service & Repair, Orthopedics to make a meaningful impact on the quality and reliability of medical device service and repair. As the Staff Quality Engineer – Service Quality, you will serve as a trusted quality and compliance partner for assigned DPS Service Centers, helping teams consistently execute Quality System requirements and deliver dependable outcomes for customers and patients.

In this highly collaborative role, you will work across Service Operations, Customer Quality, and other key functions to strengthen and harmonize service processes, deploy quality agreements and training, and promote consistent practices across assigned sites. You will use data, risk-based thinking, and structured problem-solving to monitor performance, address nonconformances, CAPAs, and audit observations, and identify opportunities for continuous improvement. This is an opportunity to influence quality beyond a single site, lead cross-functional initiatives, and help shape a compliant, efficient, and continuously improving global Service & Repair network.

DUTIES & RESPONSIBILITIES

• Be the main point of contact for quality and compliance aspects for assigned WW Service Center(s) in the assigned Region
• Ensure general compliance support for consistent and correct execution of QS procedures at all Service Centers e.g. change management strategies
• Coordinate the Regional Quality Plan and provide regional oversight of QMS execution and identify systemic compliance gaps across sites.
• Be the subject matter expert for the validation of equipment and computer system validation of equipment
• Ensure qualification and management of Suppliers related to Installation & Servicing
• Collaborate with Service Operations and Field Service to ensure global harmonization of service processes.
• Collaborate with Customer Quality representatives to ensure compliance with reporting requirements of all Service centers and accuracy of service evaluations linked to customer complaints
• Support tracking of monthly performance and quality metrics for each Service Center and attend the monthly/annual review meetings
• Coordinate and support resolution for all nonconformances, CAPAs and audit observations related to Installation and Servicing for the Netherlands Service Center and regional QMS
• Collaborate on shared/global procedures update and harmonization
• Support Service Sites internal and external audits based on sites requirements
• Conduct training related to procedural changes and coordinate with relevant stakeholders to investigate and document deviations identified at the sites.
• Manage the initiation and review of Service Level Agreements
• Responsible for communicating business related issues or opportunities to the next management level
• Conduct data driven analysis based on requirements
• Lead continuous improvement initiatives to ensure efficiency, effectiveness, and compliance
• Maintain awareness of ISO standards while developing solutions to satisfy business needs
• Performs other duties assigned as needed.
  

Required Qualification and Core Competencies for the role:

• Bachelor degree in engineering, scientific or quality and compliance disciplines. Will accept the equivalent relevant industry experience in the absence of a degree
• At least 5 years experience in Quality (medical devices and validation of equipment preferred)
• Recommended Lean six sigma Green/Black belt, Project Management Certification will be an asset for this position
• Experience in regulated ISO 13485 industries
• Excellent communications skills
• Organizational skills, ability to resolve conflicts
• Strong analytical thinking skills and the ability to work in a flexible way under time pressure in local and global teams
• Ability to make risk based decisions under time pressure
• Understands the business implications regarding quality positions and decisions
• High sense of responsibility and reliability
• Work independently within established timelines
• Experience with ETQ, Windchill and Saleforce S&R system will be beneficial
• Fluent in English
• Ability to travel if and when required (5%-10%)
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity

EXPERIENCE AND EDUCATION

• Bachelors degree in engineering or other technical field preferred.
• Experience in Medical Device environment (2-5 years).
• Recommended Lean six sigma Green/Black Belt, Project Management Certification or ASQ certification (CIA, CQE) are an asset for this position.
• Experience in regulated ISO 13485 industries.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Excellent communications and analytical skills are required.
• Ability to work in a team is required.
• Organizational skills, ability to resolve conflicts.
• Analytical/Problem solving skills.
• High sense of responsibility and reliability.
• Work independently within established timelines.
• Experience with EtQ, Trackwise, and Salesforce are beneficial for this role.
• Additional language skills are beneficial for this role.

"Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company,

operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months,

subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be

required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that,

following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by

DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be

provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes."

 

 

Vereiste vaardigheden:

 

 

Gewenste vaardigheden:

Compliancebeheer, Continue verbetering, Corrigerende en preventieve maatregelen (CAPA), Feedback geven, Inclusief leiderschap, ISO 9001, Kwaliteitsbeheersystemen (QMS), Kwaliteitscontrole (QC), Kwaliteitsnormen, Kwaliteitsprocessen, Leiderschap, Ontwikkelen van anderen, Op feiten gebaseerde besluitvorming, Standard Operating Procedure (SOP), Teammanagement, Zakelijk onderlegd

  

 

Het te verwachten bruto jaarsalaris voor deze functie ligt tussen de:

€64 000,00 - €103 040,00

 

 

Voordelen:

Naast het basissalaris bieden wij de volgende benefits*: Een jaarlijkse bonus met een vast percentage (% van het salaris) afhankelijk van de salarisschaal / land, waarbij het werkelijke bedrag is gebaseerd op de prestaties van de werknemer en de onderneming in het voorgaande kalenderjaar, of verkoopcommissies. Bovendien bieden wij vakantiedagen, minimaal 12 weken ouderschapsverlof, verlof bij overlijden van directe familie, zorgverlof, vrijwilligersverlof en welzijns programma's voor financiële, fysieke en geestelijke gezondheid. We bieden ook jubileum- en erkenningsbeloningen aan en afhankelijk van de voorwaarden van hun respectieve plannen, kunnen medewerkers - en in sommige locaties hun aanverwanten - deelnemen aan verschillende verzekeringsplannen. Ga voor meer informatie naar Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*dit is alleen voor informatieve doeleinden. Bedragen en werkelijke benefits kunnen per land verschillen en kunnen worden gewijzigd.