Job Description

Description: SUMMARY Leads WHK Quality and Regulatory Departments to assure compliance with WHK's Quality Management System and all applicable regulatory requirements to ensure a best-in-class quality culture. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Develop, implement, maintain and continually improve the WHK Quality Management System. Lead MRB meeting, ensure implementation of corrective actions and update NMR database. Management of Quality Engineers and Quality Inspectors to ensure QMS procedures and policies are followed. Develop strategic quality improvement initiatives that establish a culture of quality. Act as the primary interface with the customer and all regulatory agencies regarding all quality related questions, concerns or inquiries. Conduct ISO Awareness Training, cGMP Training and overall Compliance training with all WHK employees. Manage and make process improvements to the ECO process for new products launches and product/process changes. Work closely with Purchasing to supervise WHK Supplier Management Program. Develop, implement, and coordinate control plans and documentation for new and existing manufactured parts. Development and maintain visual aids for defect recognition. Train appropriate personnel on the use of the visual aids for defect recognition system. Develop and maintain operation specific work instructions and inspection standards. Train appropriate personnel on the use of these work instructions and inspection standards. Conduct capability studies, analyze results and report results as needed to management. Create and maintain control plans and control charts as necessary. Identify critical characteristics to be inspected for each part run in WHK manufacturing Conduct root cause analysis for discrepancies and issue corrective action when deemed necessary. Update, evaluate returned product under RMA process; interface with customer service and/or customer as necessary. Lead the initiative to drive down defect rates by determining which parts need attention. As a team leader, working directly with involved departments, the Quality Director is to systematically identify and correct the root cause of all product defects. SUPERVISORY RESPONSIBILITIES Supervise WHK Quality Manager, Quality Engineers and QA Inspectors. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Teamwork is essential for WHK's continued success, so Teamwork is an essential function of every employee's job. Teamwork drives positive results every day. Teamwork promotes positive customer relations and results in exceeding the expectations of our customers. Teamwork benefits every employee since it grows our business and increases our sales. With Teamwork, we all succeed. Without it, we all suffer. Teamwork with co-workers in the same department is just the beginning. Teamwork with every other employee, department and division is the Teamwork that is required to succeed. WE ARE WHK. . Requirements: SAFETY TRAINING To perform this job successfully, an individual must complete and maintain the following Safety Training requirements. General Safety Orientation* *CD-ROM course tailored to specific individual requirements within their job ''Training Suite". 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 Individuals with disabilities to perform the essential functions. EDUCATION AND/OR EXPERIENCE A minimum of ten years of experience in a leadership position within both Quality Assurance and Regulatory responsibilities. Must have a strong knowledge of ISO 13485 and other quality systems. Experience leading FDA/customer inspections is required. Prior experience in the Medical Device or Single Use Medical market is required. Prior experience with sterile products is a plus. LANGUAGE SKILLS Must possess the ability to express thoughts clearly, both verbally and in written context. Must have strong knowledge in working with the MS Office Suite. MATHEMATICAL SKILLS An understanding of all basic mathematical skills. A complete understanding of trigonometry and angular relationships is necessary in order to understand and interpret blueprints. REASONING ABILITY Should be familiar with the different processes required to process materials through a manufacturing environment. This knowledge would help the individual to be able to install necessary inspection points throughout the manufacturing operations. CERTIFICATES, LICENSES, REGISTRATIONS An active membership in the American Society for Quality (ASQ) and an ASQ CQE are a plus. PHYSICAL DEMANDS The physical demands described here 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 the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk and use hands to finger, handle, or feel. The employee is occasionally required to sit. The employee must frequently lift and/or move up to 50 - pounds. Specific vision required by this job include close vision, peripheral vision, depth perception and ability to adjust focus. Must have the ability to travel for business purposes. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and environmental restrictions. PI203183172