Associate Director Quality Assurance

Direct message the job poster from Medella Life

Overview

As Associate Director, Quality Assurance (Devices) you will lead and oversee the quality assurance activities for the medical device product portfolio (including device-only or drug-device combination products) within the Berlin site/region or globally from Berlin. You will ensure the Quality Management System (QMS) and device-related processes comply with relevant standards (ISO 13485, 21 CFR 820, MDSAP) and regulatory requirements (EU MDR/IVDR, FDA) and support new product introductions, transfers, manufacturing, supplier quality, post-market surveillance and audits.

Key Responsibilities

• Provide leadership for the QA function for the device business: setting strategy, monitoring KPIs, driving continuous improvement of quality systems and culture.
• Oversee the implementation and maintenance of the QMS: document control, design control, risk management (ISO 14971), supplier management, non-conformance/complaint/CAPA processes, change control.
• Ensure compliance of the device products with applicable regulations
• Lead or support internal audits, external audits (suppliers, contract manufacturers, regulatory inspections / notified body audits) and ensure effective remediation of findings.
• Support new product development and transfer to manufacturing: review and approve Quality-related documentation (design history file, verification & validation plans, device master records, production transfer protocols).
• Drive risk-based thinking across the organisation: perform risk assessments, lead root cause investigations, drive CAPA effectiveness, trend data and implement preventive actions.
• Interface cross-functionally with R&D / Design Engineering, Manufacturing, Regulatory Affairs, Supply Chain, and Commercial to ensure quality inputs are embedded from the start.
• Manage supplier quality for outsourced manufacturing/contract manufacturing organisations (CMOs) or suppliers: qualification, audits, quality agreements, monitoring.
• Represent QA in major quality issues, escalations, customer complaints, product recalls or corrections.
• Develop and manage your team: hire, train, set objectives, conduct reviews, build capability in the QA organisation.
• Monitor, report and drive improvement of quality metrics (e.g., audit findings, CAPA cycle time, supplier nonconformances, product complaints).
• Work with management on budget, resource planning and quality improvement initiatives (e.g., Lean, digitalisation of QMS).
• Manage evolving regulations and standards for medical devices, and ensure organisation readiness for changes.

Required Qualifications & Experience

• Bachelor’s degree or higher in engineering, life sciences, biomedical engineering or equivalent technical discipline - MSc or PhD in relevant field is preferred.
• 8-12+ years of relevant experience in medical device quality assurance (or combination product/device development/manufacturing) including leadership/managerial experience.
• Solid hands-on experience with device QMS, design control, risk management, supplier quality, design transfer and manufacturing transitions.
• Extensive demonstrated knowledge of EU and US device regulations: ISO 13485, 21 CFR 820, MDSAP.
• Strong leadership, communication and influencing skills across the organisation.
• Fluent English required; German language skills strongly preferred (as Berlin-based role).
• Willingness to travel (national/Europe/international) to suppliers, manufacturing sites, audits up to 20% per year.
• Experience with drug-device combination products
• Experience working in German/European device industry or with notified body audits.
• Experience implementing digital quality systems
• Experience leading organisational change, Lean or Six Sigma background.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Project Management

Industries

• Medical Equipment Manufacturing