Quality Control Manager

Bio-Rad Laboratories, Inc.
5731 W. Las Positas Blvd
Irvine, CA 92618
United States

Category

Job Description

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.

Employer