Therafirm, a Knit-Rite Company, has an immediate opening in our Ellerbe, NC facility for a Quality Manager.   Therafirm is a leading manufacturer of healthy, graduated compression stockings and hosiery.  For more company information visit www.therafirm.com and www.knitrite.com.

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

Position Responsibilities include:

·         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.

·         Ensures 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

Position 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.

Competitive Benefits include:

·         Health, dental, vision, 401K

·         Paid Vacation, Personal time, and Holiday time.

·         100% Paid Life and Disability Insurance.

·         Casual Dress Code

Send resume with salary history and minimum salary requirements to Lisa Trussell.