Lead Quality Assurance & CAPA Manager

About the job

You don’t just want to ensure quality, but actively shape and further develop it? Then you are exactly right with us. In this key role, you take on the technical leadership in the QA area and ensure that our CAPA and vigilance processes not only work but continuously improve. With your commitment, you specifically develop our quality management system further and thus make a significant contribution to sustainably reducing risks.

In doing so, you create trust with our customers, authorities, and in audits, while simultaneously strengthening our position in the market.

What you can achieve

Quality Assurance

• Technical leadership and consulting of the QA team including moderation and preparation of the weekly QA team meeting
• Monitoring the assessment of incoming customer complaints and internal nonconformities regarding severity
• Ensuring timely recording, processing, and documentation of nonconformities by the QA team
• Decision-maker for severity classification in case of uncertainties in coordination with QMB/PRRC
• Further development of QA processes, methods, and documentation for continuous improvement of quality levels
• Close collaboration with production, development, service, regulatory affairs, PRRC, and other interfaces to efficiently coordinate and operationally integrate quality-relevant topics

CAPA

• Identification, analysis, and sustainable correction of quality deviations through planning, implementation, and monitoring of appropriate CAPA measures
• Technical contact and advisor for CAPA responsible persons throughout the company
• Responsibility for planning, execution, documentation, and success control of CAPA processes according to ISO 13485 and other regulatory requirements
• Leadership and organization of the CAPA committee including regular reporting to management level
• Evaluation and approval of risk-based justifications for CAPA measures
• Systematic identification of improvement potentials in quality management
• Initiation, support, and execution of training and workshops to promote quality awareness company-wide

Vigilance

• Monitoring product safety after market launch
  Assessment of incidents, risks, and customer complaints regarding vigilance relevance
• Review and triggering of regulatory reporting obligations as well as preparation of authority reports in cooperation with the PRRC
• Analysis and evaluation of risk data from internal and external sources.
  Initiation and support of necessary corrective actions, e.g., FSN (Field Safety Notices) and FSCA (Field Safety Corrective Actions)
• Responsible for the vigilance reporting system including continuous maintenance and updating of worldwide regulatory vigilance requirements
• Interface management with regulatory affairs, PMS, PRRC, and authority contacts

Audits

• Planning, preparation, and execution of supplier and internal audits according to ISO 13485 and other regulatory requirements
• Support, evaluation, and coaching of lead and co-auditors to ensure audit competence and effectiveness of the audit program
• Support in further development of the audit program as well as in qualification and evaluation of suppliers

What distinguishes you

• Completed training/studies in a relevant field (e.g., medical technology, engineering, quality management, or natural sciences)
• Several years of professional experience in quality management or assurance in medical technology or regulated industry
• Solid knowledge of relevant standards and regulations (ISO 13485, MDR (EU) 2017/745, ISO 14971 (risk management), vigilance processes and authority requirements, MDSAP)
• Experience in planning, preparation, and execution of supplier and internal audits
• Experience in conducting and evaluating CAPA processes as well as handling nonconformities and complaints
• Ability to technically manage employees
• Strong decision-making skills and problem-solving competence
• Pronounced analytical skills combined with a structured way of working
• Very good German and English skills, both spoken and written

What to expect from us

• An open "du" culture and a family-like atmosphere
• Comprehensive onboarding as well as an individually designed introduction program with insights into various departments
• Meaningful work that improves the lives of others
• At least 5 weeks of vacation plus flex days
• Flexible working hours
• Support for professional development through targeted training and further education
• Coverage of daily sickness allowance premiums
• Free parking spaces as well as charging options for electric vehicles
• Free coffee, tea, and fresh fruit as well as 15 minutes paid break