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
- 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.
- 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.