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EMEA Quality Customer Service Program Manager

Roles & Responsibilities

  • Bachelor’s or master’s degree in engineering, Biology, or other STEM disciplines (Science, Technology, Engineering, and Mathematics).
  • Minimum of 5 years of experience in the Medical Device industry in Quality Management roles (e.g., Quality Manager, Quality Specialist, Auditor, or Consultant).
  • Strong working knowledge of ISO 13485 and track record in managing CAPA processes, internal audits, and hosting external audits (notified bodies/competent authorities).
  • Knowledge of Medical Device Regulation (EU) 2017/745.

Requirements:

  • Elaborates, analyzes and implements quality concepts, methods, tools and procedures as part of an agile/lean-oriented Quality Management System for a specific quality area or organizational unit.
  • Creates a transparent quality culture with management and provides guidance to identify, assess, and control risks throughout the design and use of the Quality Management System.
  • Coaches agile/lean project teams and leads CAPA-related activities (e.g., CAPA expert, owner, reviewer) and trains employees in a quality area.
  • Ensures compliance with quality-related standards and regulatory requirements (ISO 13485, EU MDR); manages internal and external audits; drives continuous improvement and coordinates quality networks and stakeholder collaboration.

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

We are seeking a strategic and highly analytical EMEA Quality Customer Service Program Manager to join our team. In this pivotal role, you will be responsible for defining and driving the quality roadmap for our Customer Service operations across the EMEA region.

Your mission is to bridge the gap between operational efficiency and customer satisfaction by implementing an Agile/Lean-oriented Quality Management System (QMS). You will act as a change agent, fostering a culture of transparency and continuous improvement while ensuring that our services meet the highest regulatory and internal standards.

Key Responsibilities:

  • Elaborates, analyzes and implements quality concepts, methods, tools and procedures as part of an effective agile/lean-oriented Quality Management System, in a specific quality area, or in an assigned organizational unit.
  • Creates transparent and open environment for quality culture together with management.
  • Gives guidance that risks are identified, considered and controlled throughout the design and the use of the Quality Management system.
  • Creates real-time transparency for ad-hoc analysis, instant decision making, preventive action and continuous improvement.
  • Drives innovative digital solutions to improve quality by thinking outside of the box, coaching and fostering the application of creativity methods.
  • Trains employees in a specific quality area.
  • Coaches team members of agile/lean projects or even leads projects e.g. as a CAPA expert, owner, reviewer
  • Ensures, implements and assesses quality-related standards and regulatory requirements in a specific quality area, or in organizational unit(s) assigned.
  •  Analyzes and improves a series of process steps by applying appropriate methods like Value Stream Mapping, Root cause analysis etc..
  • Coordinates a group of quality-related staff without leading the team.
  • Ensures effective cooperation with both internal and external stakeholders.
  •  Coordinates an assigned international/national quality network in a specific quality area.

Requirements:

  • Academic Background: Bachelor’s or master’s degree in engineering, Biology, or other STEM disciplines (Science, Technology, Engineering, and Mathematics).
  • Professional Experience: Minimum of 5 years of experience within the Medical Device industry, specifically in Quality Management roles (e.g., Quality Manager, Quality Responsible or Quality Specialist, Consultant or Auditor).
  • Quality Assurance: Strong working knowledge of ISO 13485 standards, Proven track record in managing Corrective and Preventive Actions (CAPA) processes, experience in planning, conducting, documenting internal audits and related follow-up, experience in hosting external audits (i.e. notified bodies, competent authorities) and related follow-up
  • Regulatory Expertise: working knowledge of Medical Device Regulation (EU) 2017/745
  • Mindset: A curious and proactive individual with a strong desire to learn and innovate. Attitude towards teamwork in an international and multicultural environment
  • Mobility: Available for travel approximately 20% of the time (visiting Siemens Healthineers/Varian sites and conducting occasional on-site client audits).
  • Location: Based in Milan, Italy.
  • Language Skills: Proficiency in English (Fluent/Professional level) is highly desirable. French is a plus

Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Healthineers’ specific businesses, please visit our company page here.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile where you can upload your CV. Setting up a profile also lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.

Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees.  These scammers may attempt to collect your confidential personal or financial information.  If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.

To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes. As an equal opportunity employer, we welcome applications from individuals with disabilities.

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