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Team Lead Manufacturing Quality Planning and Sustainment (m/f/d)

 

Team Lead Manufacturing Quality Planning and Sustainment (m/f/d)

Operations (JFG)               ·         Munich, Germany          ·          Full time

 

Locations: Munich, Germany
Time type: Full time
Job Requisition ID: JR-10667

 

Join us today and make a difference in people’s lives!

Team Lead Manufacturing Quality Planning and Sustainment (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 (Milling, PCB assembly and Assembly line)
  • 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
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 Planning and Sustainment is responsible to keep the manufacturing running and provide all needed actions on time to sustain manufacturing (SOP update, FMEA, implementation of new parts to manufacturing)
  • Improve output by process improvements                                                                         

 

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
  • Capability to apply global regulations into processes and procedures
  • 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.

Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

 

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.

 

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

 

Please click here to apply.

 

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