Senior Quality Engineer - Electrophysiology

About the role

Heraeus Medical Components is looking for a Senior Quality Engineer for its electrophysiology business unit. The role ensures that customers' specifications and quality standards are met during manufacturing, in line with the company's quality management system.

Key responsibilities

• Develop, coordinate and control actions to monitor and analyse quality performance against customer specifications and quality standards.
• Investigate high-level product or process issues, determine root causes and implement corrective actions to prevent recurrence and improve processes.
• Lead quality planning during New Product Introduction (NPI), turning customer, design and regulatory requirements into measurable quality requirements.
• Lead quality and regulatory initiatives to promote compliance in operations and engineering, and lead actions that deliver cost savings in the Quality Sustaining area.
• Develop and mentor quality engineering talent through coaching, technical guidance and professional growth opportunities.
• Promote a culture of quality, accountability, collaboration and continuous improvement.

Required profile

• Bachelor's degree in an engineering discipline or Business Sciences.
• 5+ years of experience in related positions such as Quality Assurance, Change Control and QMS.
• 4+ years leading teams of specialised people.
• 3+ years managing quality controls (SOPs, work instructions, specifications, guidelines).
• Fluent spoken and written business English and Spanish.
• ASQ-certified quality engineer or ISO 13485 auditor is a plus.

Required skills

• Specialised knowledge of Quality Assurance; understanding of CAPA, statistical analysis, SPC and Lean tools.
• Proficiency with Quality Management Systems and ERP solutions.
• Proficiency with Microsoft Office.
• Negotiation skills to drive different criteria across multidisciplinary teams.