As Quality Operations Manager, you’ll oversee a small but dedicated QA/QC team and drive continuous improvement in a high-volume, high-precision production environment. You’ll also play a key part in harmonising quality systems across international sites and contribute to global management reviews. Responsibilities:

• Lead and maintain the QMS in compliance with ISO 13485 and EU MDR 2017/745
• Act as site Management Representative during audits (recent audits: no major findings)
• Oversee QA and QC operations (2 QAEs, 2 QCIs) and strengthen team capacity
• Collaborate with US-based colleagues on cross-site quality initiatives
• Drive harmonisation and integration of quality systems globally (80% local / 20% global projects)
• Foster a culture of quality, teamwork, and continuous improvement

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 5+ years’ experience in quality management within medical devices or manufacturing
• Strong working knowledge of ISO 13485 and regulatory compliance
• Calm, balanced leadership style – able to bring structure and focus to a busy environment
• Excellent communication and collaboration skills across cultures and time zones

 

Offer:

• Competitive salary including management bonus
• Pension plan, travel allowance, and flexible working hours
• Professional growth within a global, innovation-driven organisation