Team Lead Manufacturing Quality Planning and Sustainment

Team Lead Manufacturing Quality Planning and Sustainment

LivaNova

Munich, Germany

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.

Apply Now

More Job Searches

Germany      Manager and Executive      Manufacturing and Logistics      Quality Assurance      LivaNova