Regional Quality Leader, Europe — Remote & Flexible

Trelleborg Sealing Solutions; Stein am Rhein; Hybrid; CHF 180,000 - 230,000; Full time

Benefits offered by this job

Flexible work options

International collaboration

Job summary

Trelleborg Sealing Solutions is seeking a Regional Quality Manager for Europe to lead and continuously improve the QMS across Europe, ensuring compliance with FDA, MDR/IVDR, and other regulations. The role provides direct quality leadership for Stein am Rhein and supports acquisitions and supplier quality across European sites.

You will lead regional quality teams, drive CAPA, audits, and KPI reporting while aligning with global quality strategy.

Qualifications

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

Responsibilities

• 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.
• Provide quality leadership for Stein am Rhein facility and oversee 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.
• Ensure compliance with FDA, MDR, IVDR, CE Marking, and other regulations.
• Partner with Regulatory Affairs and Operations to address compliance risks.
• Assess and mitigate risks related to materials, suppliers, products, and process changes.
• Lead investigations, escalations, and resolution of quality and compliance issues.
• Serve as the primary quality contact for customers throughout Europe.
• 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.
• Establish, monitor, and report regional quality KPIs.
• Lead CAPA processes and ensure timely resolution of nonconformances.
• Analyze quality trends and drive root-cause investigations.
• Present regional quality performance and improvement plans to leadership.
• Lead, coach, and develop regional quality teams; drive quality cost improvements.
• Build organizational capability and succession plans; support growth.
• Promote a culture of quality, accountability, customer focus, continuous improvement.
• Support acquisition due diligence and integration activities.
• Lead Management Review processes and report on QMS performance and improvements.
• Ensure regulatory registrations and core QMS support systems remain compliant.
• Support validation activities, quality training, and customer quality agreements.
• Champion AI-enabled and digital quality solutions to improve compliance and efficiency.
• Leverage analytics to identify trends, risks, and improvement opportunities.
• Drive adoption of data-driven quality practices across the region.

Skills

Quality leadership

Regulatory knowledge

CAPA expertise

Data analytics

Education

Bachelor’s degree in Engineering/Life Sciences

Master’s degree preferred

ASQ CMQ/OE or CQE

Lead Auditor certification

Job description

Trelleborg Sealing Solutions is seeking a Regional Quality Manager for Europe to lead and continuously improve the QMS across Europe, ensuring compliance with FDA, MDR/IVDR, and other regulations. The role provides direct quality leadership for Stein am Rhein and supports acquisitions and supplier quality across European sites.

You will lead regional quality teams, drive CAPA, audits, and KPI reporting while aligning with global quality strategy.