Technical Team Leader - Quality Control

Responsibilities

• Working with buyer/planner or manager, develops daily schedules for areas of responsibility to conform with monthly requirements defined by master scheduler/Plant requirements
• Manages resources to accomplish established goals of quality, quantity and cost
• Interfaces effectively with other Team Leaders to allocate resources between teams, as needed
• Supervises and ensures team compliance with all company policies, including safety, health, QSR, and ISO standards
• Prepares operating budget and capital budget for areas of responsibility accurately and on schedule
• Reviews monthly team/departmental financial reports to ensure that spending is within budget and provides corrective action and explanations as needed
• Ensures that team is appropriately staffed with trained employees
• Ensures that equipment is maintained and operated safely and efficiently
• Establishes objectives and strategies for areas of responsibility that complement plant and ISO objectives
• Identifies department training needs and implements appropriate training measures; mentor and train staff to enhance both individual and department
• Continuously analyzes operations in an effort to reduce costs and improve quality
• As requested by supervisor, prepares and submits an accurate, timely monthly report
• Establishes effective working relationships with other Team Leaders/Managers to ensure that plant objectives are met
• Responsible for the performance management process for staff
• Creates and maintains measurements for the team’s performance (Daily/monthly goals, inventory accuracy, backorders, etc.)
• Responsible for initiation of Nonconformance Reports as required
• Responsible for QC House Standards – selection of, crossover studies, data summaries, inventory, performance and trending (QC)
• Proposes solutions or recommends actions for resolution of technical issues
• In conjunction with the Training Coordinator, responsible for employee technical training plans

Qualifications

• Education: Bachelor’s degree in a life sciences, or certified Medical Technologist (MT)/Medical Laboratory Scientist (MLS)
• Experience: Minimum of 5 years progressive in a laboratory or Quality Control environment, experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device (IVDD) is a plus with a minimum of 2 years supervision
• Skills & Capabilities: Understanding of Good Manufacturing Practice (GMP), Good Laboratory Practices (GLP); Demonstrated ability to organize work assignments; Knowledge of laboratory equipment, QC Instruments; Proficiency in common laboratory techniques; Basic management knowledge; Technical writing skills, including ability to write protocols, test procedures and other technical reports and documents; Knowledge of QC testing procedures; Previous regulatory audit experience a plus; Employee relations; Business acumen; Oral and written communication skills