Join us in shaping and enhancing quality beyond mere assurance! This key role offers a collaborative work environment with great benefits.
Tasks
Lead the QA team and facilitate weekly meetings effectively.
Oversee customer complaints and internal non-conformities assessments.
Drive continuous improvements in CAPA and Vigilance processes.
Skills
Degree in a relevant field with extensive QA experience required.
Strong decision-making and problem-solving abilities essential.
Excellent analytical skills with a structured approach needed.
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
Ready to change the world of eyesight? Then we look forward to receiving your complete application documents. For questions, Fabio is happy to assist you. Direct applications are preferred.
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