SUMMARY
Develops, implements, and coordinates product assurance process to prevent or eliminate defects in new or existing products by performing the following duties personally or through subordinate associates.
EDUCATION and/or EXPERIENCE
Bachelors Degree plus previous supervision experience required. Training and leadership experience in SPC required. Lean Manufacturing and TQM preferred. Previous FDA experiences a plus. High computer competency expected.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individual with disabilities to perform the essential functions.
GMP & PPE REQUIRED
Own training and enforcement all GMP regulations for the plant. Operators on the floor or anyone moving through the work area must follow the GMP rules in their employee handbook, which includes the required hairnets, beard nets, and earplugs. It is also required that all personnel wear safety glasses while operating a forklift.
ESSENTIAL DUTIES & RESPONSIBILITES
Include the following. Other duties may be assigned.
• Develops, trains and leads all aspects of Quality plant wide
• Suggests and implements alternative methods and procedures in solving problems and meeting changing market opportunities.
• Cooperates with management personnel in formulating and establishing company policies, operating procedures, and goals.
• Develops initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements, and operational procedures within program.
• Evaluates contents of reports from product assurance processes with department heads and confers with top management personnel. Essential in preparing annual operating budget for product assurance department.
• Establishes testing parameters that will support customer, regulatory and company requirements. Use of Standard Quality Tools in collecting, formatting and reporting data is required.
• Conducts management meetings with department heads to establish, delineate, and review organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives.
• Maintains and improve current methods to support SQF Level 3 status.
• Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
• Visits and confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders, and vendor quality standards.
• Works closely with Director of Corporate Quality and Corporate lab regarding new products, regulations and potential quality concerns.
• Reviews technical publications, articles, and abstracts to stay abreast of technical developments in the industry.
• Oversees HACCP plan for the plant.
• Oversees SQF plan for the plant.
• Oversees FDA requirements plant wide.
• Oversees Plant Sanitation Program plant wide.
• Manages Water Processing Systems
SUPERVISORY RESPONSIBILITES
Directly supervises approximately 5 employees in the Quality Assurance Department. Conducts supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
CERTIFICATES, LICENSES, REGISTRATIONS
Certification as a CQM or CQE or equivalent
