Quality Section Lead

Quality Section Lead

Permanent 

 

 

About Heraeus

Making displays foldable? Help hearts beat with micro-particles? Work on solutions involving precious metals? As a family-owned global technology group we help our customers to always being one step ahead.

About Heraeus Medevio

Heraeus Medevio combines medical technology expertise with collaborative partnerships. Together with medical device manufacturers, we develop and implement solutions for defined applications. As part of the Heraeus Group, we support the professional development of our employees and offer opportunities for career development, depending on the role, location and operational conditions.

To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

 

Job Purpose: The Quality Section Lead for Quality Operations is responsible for leading and continuously improving Quality Operations across manufacturing and support areas.  This role provides strategic and day‑to‑day leadership to Quality Engineering and Quality Technician teams, ensuring robust product quality, compliance with applicable regulatory and quality system requirements, and effective support of manufacturing operations.  

Main Responsibilities:

• Build a high-performing team through coaching, technical training, succession planning, and performance management to strengthen organizational quality expertise. 
• Oversee workload planning, prioritization, and resourcing to support quality operations. 
• Provide quality engineering oversight and escalation support for daily manufacturing activities.  
• Support containment, disposition, and resolution of production quality issues.  
• Ensure production issues are assessed for product risk and compliance impact.  
• Enable timely decisions that support production continuity without compromising quality. 
• Oversee production nonconformances and customer complaints ensuring investigations are technically sound, data‑driven, and identify true root cause with appropriate corrective/preventive actions. 
• Serve as a quality engineering management in customer meetings and interfaces.   
• Escalate high risk issues to Quality Manager and Quality Director.   
• Provide quality engineering support for process, equipment, and product changes ensuring changes are risk‑assessed and appropriately evaluated for quality and compliance impact.  
• Partner with Engineering and Manufacturing on prioritization, resourcing and change execution. 
• Quality lead for internal and external change status tracking.  
• Lead continuous improvement initiatives to strengthen quality procedures and controls.  
• Drive standardization of tools, templates, and best practices across quality engineering. 
• Analyze quality data and metrics to identify trends, risks, and opportunities for improvement 
• Support internal and external audits as needed. 
  

Required Qualifications:

• Bachelor’s degree in engineering discipline or Business Sciences. 
• Fluent in spoken and written business English and Spanish 
• 10+ years of experience in similar position.  5+ years Quality or Operations Quality within the medical device industry, including experience in process validation and root cause analysis. 
• 2+ years leading work teams of specialized people. 
• Deep understanding of root cause analysis, statistical analysis, process validation,  equipment and test method validation, risk management (ISO 14971), and quality system regulations.   
• Proficient in using Quality Management Systems and ERP solutions. 
• Proven ability to lead cross-functional teams, drive root cause analysis using structured methodologies and make data-driven decisions that improve process capability, product quality, and team performance. 
• Demonstrated ability to build high-performing teams by providing mentorship, technical guidance, and career development opportunities that strengthen individual capabilities and overall departmental performance. 
• Medical device, EN ISO 13485 and/or FDA QMSR experience 

Preferred Qualifications: