Process Quality Lead (f/m/d) (MedTech)

Location: Norderstedt, Schleswig-Holstein, Germany

Salary: €75,000–€118,450 base pay annually

Company

Healthcare and MedTech organization developing medical technologies and solutions across prevention, treatment, and care.

What you will do

• Lead investigations into manufacturing non-conformances, process failures, product complaints, near misses, and escalation investigations.
• Identify root causes and guide the implementation of corrective and preventive actions, including CAPA.
• Review quality trends and recommend process, equipment, and system improvements.
• Provide technical leadership to cross-functional teams and guide manufacturing supervisors through in-depth investigations.
• Prepare procedures, protocols, technical reports, presentations, and investigation documentation.
• Train manufacturing personnel in troubleshooting, FMEA, applied statistics, and QSR/ISO requirements.

Requirements

• Bachelor’s degree required; an engineering or science degree is preferred. A master’s degree is preferred.
• At least 6 years of professional experience, including 4 years in QSR/ISO-regulated operations; medical device manufacturing experience is preferred.
• Thorough knowledge of QSR, GMP, ISO, applied statistics, and failure mode analysis techniques.
• Bilingual English and German or Spanish communication skills.
• Advanced Microsoft Office and software application skills, with strong technical reporting, presentation, communication, negotiation, and interpersonal abilities.
• Availability for first, second, and third shifts, 12-hour shifts, weekends, holidays, and irregular working hours; up to 10% travel may be required.

Nice to have

• Experience in a quality role within manufacturing.
• Knowledge of lean supply chain management, process control, process improvement, and team management.
• Experience developing others and leading technical professionals or project teams.

Culture & Benefits

• Annual bonus with a target based on pay grade and location, subject to individual and company performance.
• Vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Service anniversary and recognition awards.
• Eligibility for insurance plans may be available under the applicable plan terms.