Overview
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.
Responsibilities
- 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.
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
minimal supervision.
Ability to remain calm and receptive in fast paced situations.
Qualifications
- 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)
Physical Requirements :
- General office setting.
- Exposure to moderate noise and light levels within manufacturing facility
- Requires close visual acuity when working with computers, etc.
- Maintain a physical presence in the area of responsibility
- Proper attire / clothing and personal protective equipment / clothing as required within Controlled Production Areas
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