The posting
Position Summary Responsible for the day to day quality support for the manufacturing function and the supervision of the quality department inspection staff. Primary Functions
Reviews reports from each shift and reports discrepancies to appropriate personnel. Sends complete and accurate inspection and certification data to the customer and maintains Good Manufacturing Practices. Understands and utilizes statistical tools and techniques to further enhance the prevention-based quality system. Assures that all non-conforming materials are properly identified, isolated, and dispositioned and that any necessary corrective actions are adequately communicated, implemented, and monitored for effectiveness. Reviews each new or existing job on a period basis to ensure that customer requirements are continually satisfied and helps to identify and implement any necessary corrective actions. Monitors the calibration program, updates the database as required, and ensures all test and measurement equipment is calibrated in accordance with procedures. Assists the quality manager with the implementation of quality initiatives, new or revised policies and procedures, corrective actions and helps to monitor resulting data for effectiveness. Ensures training is in place and effective for new hires within the quality department. Provides ongoing training to subordinates to ensure continued growth and improvement in all aspects of their responsibilities. Provides timely completion and submission of performance reviews and evaluations for subordinates along with recommendations for corrective actions and promotion potential. Provides counseling and disciplinary actions both verbal and written when required. Maintains enforcement of and compliance with policy and procedures to ensure that the results conform to planned and/or desired results and to assure a safe working environment is maintained. Manages the corrective action activity (internal, external, and supplier) by coordinating input from the various manufacturing teams to provide continuous improvement of our daily activity and to provide prompt and accurate responses to our customers in potentially difficult situations. Supports the development, daily use, and long-term improvements of the ISO 9001 system and cGMP requirements through internal audits, process monitoring, and creative thinking.
Key Qualifications
Associates degree or equivalent in related field. Bachelor’s Degree preferred. Background in ISO certified manufacturing environment. Hands on experience as a Quality Technician, a Quality Systems Technician, or a Quality Department supervisor/manager. Three to five years processing injection molding or related experience preferred. Thorough understanding of quality standards and systems including Statistical Process Control.
Physical Requirements The conditions herein are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions. Please refer to the Physical Job Description, which is contained as a separate document, for more detail. Environment: Normal manufacturing environments; work with machinery and media in or around confined spaces; exposure to chemicals, grease and oils. Physical: Sufficient physical ability to perform heavy lifting and carrying; reaching, kneeling, crawling, climbing; standing for moderate periods of time. Vision: See in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents. Hearing: Hear in the normal audio range with or without correction. Other: Ability to work overtime or occasionally on weekends with short notice.
