Quality Section Lead - Quality Operations

About the role

Heraeus Medevio, a Heraeus Group company combining medical technology expertise with partners, is looking for a permanent Quality Section Lead for Quality Operations. The role leads and continuously improves quality across manufacturing and support areas, giving strategic and day-to-day leadership to the Quality Engineering and Quality Technician teams while ensuring product quality, regulatory and quality system compliance and support for manufacturing.

Key responsibilities

• Build a high-performing team through coaching, training, succession planning and performance management, and oversee workload planning and resourcing.
• Provide quality engineering oversight and escalation support for daily manufacturing activities, and support containment, disposition and resolution of production quality issues.
• Ensure production issues are assessed for product risk and compliance impact, and escalate high-risk issues to the Quality Manager and Quality Director.
• Oversee production nonconformances and customer complaints so that investigations are technically sound, data-driven and lead to root causes and corrective/preventive actions.
• Support process, equipment and product changes, acting as quality lead for internal and external change status tracking.
• Lead continuous improvement, standardize tools and templates, analyze quality data and metrics, and support internal and external audits.
• Serve as quality engineering management in customer meetings and interface with Engineering and Manufacturing.

Required profile

• Bachelor's degree in engineering or business sciences; fluent spoken and written business English and Spanish.
• 10+ years of experience in a similar position, including 5+ years in quality or operations quality within the medical device industry (process validation and root cause analysis).
• 2+ years leading work teams of specialized people.
• Preferred: ASQ certified quality engineer, ISO 13485 auditor, Six Sigma, and medical device, EN ISO 13485 and/or FDA QMSR experience.

Required skills

• Root cause analysis, statistical analysis, process validation, equipment and test method validation, risk management (ISO 14971) and quality system regulations.
• Proficiency with Quality Management Systems and ERP solutions.
• Proven ability to lead cross-functional teams and make data-driven decisions.

Candidates are invited to apply online or contact the employer directly; the application is handled confidentially.