CAREER OPPORTUNITIES

• QUALITY MANAGER

Job Title: Quality Manager
Department:  Quality
Status:  Exempt

General Description

The position is responsible for developing, leading and executing the Quality Strategy for the
Ellerbe, NC plant, while collaborating with Plant Management, Operations, and other functional groups.

Duties/Responsibilities

Manages the development, implementation and maintenance of quality assurance policies and activities, as outlined in the Quality Manual, for Class I and Class II medical products. Provides direction, management and development of Quality Control team members. Manages the evaluation of customer complaint records and maintenance until closure of files. Assures that corrective actions and preventive actions are established, tracked and trended and that root cause elimination is completed for identified issues by appropriate function and to implement process improvements. Oversees the development and maintenance of the Document Control System. Reviews, approves and manages internal and external standard operating procedures for compliance with Quality Policy. Insures compliance to the requirements of the FDA regarding process, design and development of new products and processes. Provides guidance and interpretation of regulatory requirements, as needed. Assists in the development and submission of 510(k)’s

Qualification Requirements

Bachelor’s degree in Engineering, Life Sciences or Textiles preferred. 5 + years experience in Quality Assurance functions, preferable in the medical device industry, however relevant plant operations and management experience will be considered. Experience in quality within an ISO or cGMP manufacturing facility. Familiar with Six Sigma and/or a history of Lean manufacturing preferred. Excellent written and oral communication skills and the ability to communicate and work effectively across departments and with customers. Strong leadership and management skills are required: Ability to provide direction, facilitation, support, reinforcement and coaching to individuals and teams. Proficiency in quality systems and manufacturing methodologies. Training and experience in developing, managing and auditing quality systems. Proficient in the use of a wide variety of computer applications. Reports directly to the COO/CFO at an external location.

To apply for job openings, please download the Knit-Rite Employment Application.