Quality Systems Specialist

KRK Medtronic B.V.; Heerlen; On-site; EUR 55,000 - 82,000; Full time

Benefits offered by this job

Competitive salary package

Incentive plan

Job summary

Medtronic in Heerlen, Netherlands, seeks a Quality Systems Specialist to embed quality in day-to-day distribution and warehousing operations. You will drive ISO 13485 certification activities, manage risks, monitor KPIs, and collaborate with cross-functional teams to improve process performance and product quality.

The role emphasizes a quality mindset, root-cause analysis, and continuous improvement across supply chain processes, with English required and Dutch beneficial.

Qualifications

• Bachelor's degree in Quality, Engineering, Life Sciences, Supply Chain, Business, or a related field.
• Min. 2 years of relevant work experience in a highly regulated environment (e.g., Medical Device Technology, Pharmaceutical, Automotive or Medical Logistics).
• Problem-solving and analytical skills with the ability to identify issues, determine root causes, and implement effective solutions.
• Strong communication and collaboration skills.
• English proficiency; Dutch language would be beneficial.

Responsibilities

• Serve as the primary quality contact for processes performed within local Distribution Centers.
• Partner with process owners to build quality knowledge and drive continuous improvement.
• Manage ISO 13485:2016 certification activities and ensure policy compliance.
• Monitor KPIs to identify trends, drive corrective actions, and support improvements.
• Conduct internal audits and Gemba Walks to assess process effectiveness and implement improvements.
• Embed a Quality mindset across the organization to put patients first.

Skills

Problem-solving

Analytical skills

Communication

Collaboration

Quality management systems

CAPA

Auditing

Gemba Walks

Risk management

Education

Bachelor's degree in Quality, Engineering, Life Sciences, Supply Chain, Business, or related field

Job description

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Join Medtronic as a Quality Systems Specialist and help ensure that quality and compliance are seamlessly integrated into distribution operations. Based in Heerlen, the Netherlands, you will play a key role in implementing and maintaining the Quality Management System, driving compliance, and supporting the reliable delivery of products that improve patients' lives. At Medtronic, we're committed to improving outcomes for patients through innovative healthcare solutions. Achieving that goal depends on talented people who bring expertise, curiosity, and a passion for continuous improvement. This is your perfect opportunity to join us, contribute to the Medtronic mission and Put Patients First.

A Quality Systems Specialist within the Global Deliver Quality organization ensures quality requirements are effectively integrated into day-to-day distribution and warehousing activities. The role is responsible for embedding quality requirements into operational processes, proactively managing risks, and driving continuous improvement throughout the supply chain. The specialist serves as a key connector between cross-functional stakeholders, including Distribution Center Operations, Supply Chain, and Operating Unit Quality teams. The successful candidate will have a visible impact by improving process performance, strengthening inspection readiness, reducing quality risks, and enabling teams to consistently deliver high-quality products to patients.

Primary Responsibilities

• Serve as the primary quality contact for processes performed within local Distribution Centers.
• Partner with process owners to build quality knowledge, support process implementation, and leverage quality and project management tools to drive continuous improvement.
• Manage ISO (International Organization for Standardization) certification activities for the applicable ISO 13485:2016 and provide expertise and guidance in interpreting internal and external policies and/or regulations to assure compliance.
• Monitor and analyze Key Performance Indicators (KPIs) to identify trends, drive corrective actions, and support continuous improvement initiatives.
• Conduct internal audits and Gemba Walks to assess process effectiveness, verify compliance, and collaborate with operational teams to implement improvements.
• Increase awareness on Quality topics and embed a Quality mindset in the organization to put patients first and support local organizations on identifying improvement areas.

Required Qualifications

• Bachelor's degree in Quality, Engineering, Life Sciences, Supply Chain, Business, or a related field.
• Min. 2 years of relevant work experience in a highly regulated environment (for example: Medical Device Technology, Pharmaceutical, Automotive or in a (Medical) Logistics operational environment).
• Problem-solving and analytical skills with the ability to identify issues, determine root causes, and implement effective solutions.
• Strong communication and collaboration skills.
• Excellent command of the English language both verbal and written, command of the Dutch language would be beneficial.

Preferred Qualifications

• Experience within a medical logistics environment.
• Working knowledge of quality management systems (ISO 9001 /ISO 13485), including CAPA, nonconformance management, change control, document control, and risk management.
• (Lead) Auditor certifications / Experience in supporting audits or inspections.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

• Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values.
• We recognize their contributions. They share in the success they help to create.
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Netherlands: 54,800.00 EUR - 82,200.00 EUR | The final salary within this range will be determined based on objective, job-related criteria, including relevant experience, skills and qualifications, in accordance with our compensation framework.
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.

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