Quality Manager (m/w/d) in Stein am Rhein

Sista ansökningsdag Plats: CHE - Stein am Rhein

The Regional Quality Manager for Trelleborg Medical Solutions (TMS) – Europe leads and continuously improves the Quality Management System (QMS) across Europe, ensuring quality, regulatory compliance, and operational excellence in alignment with global quality strategy. The role provides direct quality leadership for Stein am Rhein, supports quality teams across TMS European sites, serves as the region’s primary customer-facing quality leader, and drives quality integration for acquisitions. The position oversees compliance with FDA, MDR/IVDR, and other applicable regulations while proactively managing quality, supplier, and product-related risks. This role is a member of the regional leadership team.

What You’ll Do

Quality Management System Leadership

• Lead and maintain the regional QMS in alignment with global quality strategy and corporate requirements.
• Standardize quality processes and best practices across European operations.
• Ensure compliance with applicable quality standards, certifications, and regulations.
• Partner with Global Quality Systems to support audits, management reviews, and system effectiveness.
• Lead QMS integration activities for acquisitions and expansion initiatives.

Manufacturing Quality Oversight

• Provide quality leadership for the Stein am Rhein facility and oversight of European quality teams.
• Establish and monitor site quality objectives aligned with business goals.
• Ensure effective quality controls across manufacturing and supply chain processes.
• Drive continuous improvement to enhance quality, process capability, and operational performance.

Regulatory Compliance

• Ensure compliance with FDA, MDR, IVDR, CE Marking, and other applicable regulations.
• Partner with Regulatory Affairs and Operations to address compliance risks and emerging requirements.
• Assess and mitigate risks related to materials, suppliers, products, and process changes.
• Lead investigations, escalations, and resolution of quality and compliance issues.

Customer and Supplier Quality Management

• Serve as the primary quality contact for customers throughout the European region.
• Support customer audits, quality reviews, and complaint resolution activities.
• Partner with Supply Chain and Supplier Quality to ensure supplier compliance and quality performance.
• Drive supplier investigations and corrective actions as needed.

Performance Management and Continuous Improvement

• Establish, monitor, and report regional quality KPIs.
• Lead Corrective and Preventative Action (CAPA) processes and ensure timely resolution of nonconformances.
• Analyze quality trends and drive root-cause investigations and corrective actions.
• Present regional quality performance and improvement plans to leadership.

Leadership and Team Development

• Lead, coach, and develop regional quality teams while driving quality cost improvements.
• Build organizational capability and succession plans to support growth.
• Promote a culture of quality, accountability, customer focus, and continuous improvement.
• Support acquisition due diligence and integration activities.
• Lead Management Review processes and report on QMS performance and improvement opportunities.
• Ensure regulatory registrations and core QMS support systems remain compliant.
• Support validation activities, quality training, and customer quality agreements.

AI, Digital Quality & Data Analytics

• Champion AI-enabled and digital quality solutions to improve compliance, efficiency, and decision‑making.
• Leverage analytics to identify trends, risks, and improvement opportunities.
• Drive adoption of data‑driven quality practices across the region.
• Support digital transformation initiatives that enhance quality system effectiveness and operational performance.
• Reports QMS performance and improvement opportunities during Management Review meetings; prepares agendas and maintains meeting records.

What You’ll Bring

Education

• Bachelor’s degree in Engineering, Life Sciences, Quality Management, Manufacturing, or a related technical field required.
• Master’s degree preferred.
• ASQ certifications (CMQ/OE, CQE), Lead Auditor, or equivalent preferred.

Experience

• 10+ years of quality management experience in a regulated manufacturing environment.
• 5+ years of leadership experience managing quality organizations across multiple sites.
• Experience implementing and maintaining Quality Management Systems within global manufacturing organizations.
• Strong knowledge of FDA Quality System Regulations and European regulatory requirements.
• Experience supporting customer and regulatory audits, CAPA, internal audits, supplier quality, complaint handling, and quality metrics.
• Experience with acquisitions, quality system integration, and organizational change initiatives preferred.
• Experience working in a matrixed global organization preferred.

What We Offer

• A modern, engaging work environment with opportunities for growth and continuous learning
• International collaboration and a supportive team culture, including flexible and remote work options
• Participation in impactful projects with exposure to diverse and interesting business processes
• Commitment to innovation, excellence, sustainability, and social responsibility - your work contributes to digital transformation and positive environmental and social impact

Trelleborg is an Equal Opportunity Employer.

We value diversity and appreciate the unique experience and expertise that people from different backgrounds bring to our business. Our ability to innovate and develop groundbreaking technologies is one of our greatest strengths - and our people make it possible.

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