Quality Control Supervisor - Preanalytics (m/f/d)

Your Profile:

• Bachelor's Degree in Science, life sciences, or related field; Bachelor's Degree is preferred
  
• 3 years of relevant leadership experience in a medical device (ISO 13485 preferred) or similar manufacturing environment
  
• 2 years GMP, GDP, and GLP work experience in a Quality Control laboratory setting
  
• Advanced-level experience with laboratory testing equipment, instrumentation, and analysis, as well as laboratory data processing and review
  
• Intermediate-level experience with CAQ (Computer Aided Quality) inspections systems
  
• Intermediate-level MS office skills and communication & data management computer skills
  
• Intermediate-level knowledge with basic statistic and calculations; proficient knowledge in applicable chemical calculations preferred
  
• Must be able to stand and walk for up to 8-12 hours
  
• Must be able to lift up to 70 lbs
  
• Must have appropriate vision to perform detailed quality inspections as outlined in SOP's or TP's

Your Tasks:

• Leadership (supervision and mentorship) of various direct-report teams
  
• Tracking attendance of direct reportsCoordinate daily activities to meet departmental KPI's
  
• Support quality validations activities
  
• Follow appropriate steps for the identification and handling of nonconforming product
  
• Release of Incoming Goods Inspections according to valid procedure(s)
  
• Review and approval of half-finished and finished Vacuette products according to valid procedure(s)
  
• Complete required activities in SAP such as transfers, review, quality hold and releases
  
• Organize and perform special testing in cooperation with QCM PA-L
  
• Perform training and retraining for QC and production personnel
  
• Preparation, edition, and distribution of quality or related documents
  
• Perform periodic inventory and order laboratory supplies as needed
  
• Support maintenance of testing equipment in laboratory and manufacturing including scheduling and/or performance of internal/external calibrations as required
  
• Support administrative duties as assigned
  
• Support for In-process inspections and in-coming goods inspections as needed
  
• Other duties as assigned
  
• Training of new and/or existing QC employees regarding QC procedures and use of equipment
  
• Release/scrap ERP transactions of product according to valid procedures
  
• Evaluation of products according to valid procedures
  
• Review of and corrections to related QIRs in cooperation with QCM PA-L, Q-ENG-L or designee

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