The Quality Control Manager establishes directions and goals within one or more quality control departments and ensures conformance/compliance to internal procedures and external standards; and ensures adequate resources are available to meet delivery standards for internal and external products. This position interacts regularly with Operations Management to support global business direction & identify areas in need of improvement.
- Maintain first-hand understanding of the state of the department(s) by spending an effective amount of time in the department(s).
- Ensure work order status is updated in a timely manner.
- Maintain and evaluate KPI’s for productivity and evaluations.
- Recognize, develop and utilize natural leaders.
- Must be heavily involved with all personnel matters including employee performance issues, corrective action processes, and employee
development plans and actions.
- Drive quality and efficiency improvements.
- Provide direction/guidance to ensure that expectations and goals are clear and understood.
- Ensure work is being completed in a safe, sanitary and orderly environment.
- Ensure area functions effectively independent of leadership oversight.
- Support audits, investigations and tours within the department.
- Ensure compliance of, and adherence to, internal procedures and processes.
- Initiate actions to improve quality and efficiency.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
- High School Diploma or GED required.
- Bachelors degree in Engineering, Management or a related field; or experience of such kind and amount as to provide a comparable background preferred.
- Minimum 2 years experience in manufacturing management preferred.
- Knowledge of/or training in ISO, GMP and CFR standards.
- Computer proficiency, experience with Microsoft products (Word and Excel).
• Must be able to sit at desk, in meetings and/or work on a computer
• Physically capable of standing, stooping, kneeling, climbing, reaching, twisting and bending with or without reasonable accommodation
• Climbing a mobile ladder and/or other types of ladders on occasion with or without reasonable accommodation
• Must perform PPE gowning procedures to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on occasion
• Potential limited exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required
• Ability to work under specific time constraints
• Laboratory, warehouse and office setting