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Director, global quality programs & qms

Alken
Publiée le 6 février
Description de l'offre

Director, Global Quality Programs & QMS

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Date: Jan 27, 2026

Location: Alken, BE, 3570 Karlsbad-Ittersbach, DE, 76307

Company: Datwyler

In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million.

Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...

Director, Global Quality Programs & QMS

The Director, DDH Global Quality Programs & QMS, is accountable for the strategic design, governance, and continuous improvement of the DDH Global Quality Management System, while serving as the primary quality interface to customers and regulatory authorities.

This role defines and drives global quality standards, systems, processes, and transformation initiatives to ensure consistent, compliant, and efficient quality management across all DDH sites and functions. The position plays a key role in elevating quality maturity, strengthening customer confidence, and ensuring regulatory excellence in a highly regulated healthcare environment

Key Responsibilities

Customer Quality & Regulatory Affairs

1. Ensure customer-oriented quality communication and support for new product introductions in close collaboration with customer facing teams
2. Ensure customer quality requirements are systematically captured, translated, and embedded into organizational processes and product requirements
3. Drive excellent with key strategic customers in collaboration with Global Quality Operations, Local Quality teams and the Commercial Organization

Global Quality Governance & Systems

4. Own and continuously improve the DDH Global Quality Management System (QMS), in collaboration with Corporate functions
5. Define and maintain global quality standards, policies, and procedures
6. Ensure alignment and compliance with regulatory requirements (, GMP, ISO, FDA, EU)
7. Serve as the primary quality interface to customers and regulatory authorities, representing DDH on quality, compliance, and governance topics

Quality Excellence & Transformation

8. Lead quality transformation initiatives to constantly raise organizational quality maturity
9. Drive harmonization and simplification of quality processes across sites
10. Support business process definition and excellence in execution of non-quality owned processes
11. Introduce and scale best practices, digital tools, and data-driven quality methods

New Product Introduction (NPI) Quality Support

12. Act as the global quality sponsor for the New Product Introduction (NPI) framework within DDH, ensuring alignment with the global QMS and regulatory requirements
13. Define and govern quality-related NPI deliverables, in close collaboration with R&D, Operations, Regulatory Affairs, and Project Management
14. Ensure effective integration of design control, risk management ( FMEA), validation (IQ / OQ / PQ), and change management within the NPI process
15. Support successful deployment and adoption of the NPI process, including training, and capability building across functions and sites
16. Provide expert guidance, coaching, and escalation support to NPI project teams to ensure compliant and efficient execution
17. Ensure systematic incorporation of customer and regulatory requirements into new product developments

What We’re Looking For

18. Master’s degree in Quality, Engineering, Life Sciences or related field; MBA is a plus.
19. 10+ years of experience in Quality leadership roles within regulated, multi-site manufacturing environments.
20. Proven expertise in global QMS ownership, governance, and continuous improvement.
21. Strong knowledge of global regulatory frameworks ( GMP, ISO, FDA, EU regulations) and audit/inspection readiness.
22. Demonstrated track record in quality transformation, harmonization, and process standardization.
23. Experience with digital QMS solutions, quality KPIs, and data-driven quality management.
24. Strong leadership, stakeholder management, and communication skills in a global matrix organization.

What We Offer

25. Attractive compensation package that rewards your expertise and impact.
26. Flexible working arrangements with hybrid options to support a healthy work-life balance.
27. Continuous learning and development opportunities to help you grow your skills and advance your career.
28. The chance to work with cutting-edge technologies across exciting, fast-evolving industries.
29. A collaborative, high-performing team environment where your ideas and contributions truly make a difference.

Ready to join us? Click “Apply”

Datwyler is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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Be yourself at Datwyler

We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas.

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Director, global quality programs & qms
Alken
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