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Quality Control Manager

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Quality Control Manager

  • 2021-24851
  • Irvine, California, United States

Provides leadership and direction in quality control. Develops and implements programs for product testing, trend analysis, compliance with Good Manufacturing Practice/Good Laboratory Practice (GMP/GLP) in support of facility-wide compliance and product quality goals. These might include ISO and other quality initiative implementation. Plans and executes staff strategies to assure on-time completion of testing. Responsible for release of highly regulated and critical products

Responsibilities

  • Manages QC for a production plant with a high degree of complexity.
  • Plant Complexity as a combination of number of SKUs produced, Raw Materials, annual NPIs and regulatory complexity.
  • Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
  • Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.
  • Oversees 20+ direct and indirect reports, including QC Supervisors, Quality Control Technicians and Quality Control Specialists.
  • Management responsibility for multiple product lines in one or more production sites.
  • Drives all quality related issues.
  • Develop QC and product costing models.
  • Manages department budgets.
  • Coordinates with Technical Support to review, investigate and report out on Out of Box Failures (OBFs) and customer complaints.
  • Facilitates Monthly Cross-Functional Quality Meeting.
  • Conducts Failure Mode and Effects Analysis (FMEAs) and develops fishbone analysis, control charts, and capability studies to define QC specifications.
  • Creates and monitors control charts for all critical products.
  • Develops, implements and maintains technical control systems and activities.
  • Manages ongoing collection, analysis and communication of QC data.
  • Defines and specifies the implementation of standards, methods and procedures for testing and evaluating the precision, accuracy and reliability of company products.

Qualifications

  • Bachelor’s degree or equivalent in a related field.
  • Advanced Degree preferred.
  • 10+ years quality control or manufacturing experience.
  • 8 + years of supervisory experience.
  • Strong communication, public-speaking, decision-making, MS Office, and negotiation skills.
  • Strong customer orientation and focus.
  • Excellent technical and analytical skills required.
  • Knowledge of the device/drug/biotech manufacturing process. 
  • Familiarity with SAP or similar ERP systems a plus.
  • Thorough understanding of  ISO 13485, FDA regulations, GMP and GLP requirements required.
  • Experience with department budgets.

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