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Team Lead Quality Planning
vor 4 Monaten
Join us today and make a difference in people's lives
Team Lead Quality Planning (M/F/d)
Responsibilities and Tasks
Quarantine Area
- lead the MRB
- process all parts in quarantine area
- ensure correct NCR description and quantity of parts
- start and follow up on activities
Manufacturing process improvement
- internal manufacturing processes in scope
- close connection to manufacturing areas
- technical knowledge of manufacturing processes to investigate the root cause of deviations
- follow up if corrective actions have been correct addressing the issue
- create a plan of how to track and follow up on quality issues in Manufacturing
Part qualification
- lead the FAI Team
- ensure FAI documentation is complete
- ensure part qualification is closed
- communicate issues with FAI to manufacturer (external & internal)
Calibration / Qualification activities
- Responsible to have all calibrations of Equipment used at the Munich site performed on time
- Qualification of new devices
Deputy of Manager Operations Quality
- handling all topics of the department Quality Planning in case of absence of the Manager
Sustainment
- With a team of engineers, the Team lead Manufacturing Quality and Sustainment is responsible to keep the manufacturing running and provide all needed actions on time to sustain manufacturing
**Requirements**:
- University degree in an engineering field or a similar qualification, ideally in the MedTech area
- Some years' work experience in the operations or quality assurance field and working with Quality System Regulations (e.g., MDR, ISO 13485, 21 CFR 820) with focus on operations areas
- Detailed knowledge of regulatory requirements of Medical Devices (ISO 13485:2016, 21 CFR 820) would be a plus
- Interdisciplinary technical knowledge and hand on mentality
- Excellent organizational and leadership skills
- Fluent German and English skills, written and spoken
- Knowledge of problem-solving techniques as well as a strong background in Lean conversion of a manufacturing site
- Experience in leading a team
Our commitment to Diversity & Inclusion:
- LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination._
Background Checks at LivaNova:
- Upon successful completion of the hiring process an offer may be extended. Please note, LivaNova reserves the right to conduct background investigations and/or reference checks on all its potential employees, where permitted by local legislation. This offer therefore, is contingent upon a clearance of such a background investigation and/or reference check, and can be rescinded, where permitted by local legislation, based upon data received in the background check and/or refusal to cooperate with or any attempt to affect the results of this check._
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