Quality Manager

POSITION SUMMARY Develops and maintainsa quality system specific to ISO 9001:2015, ISO 13485:2016 and FDA QSR Part 820 to ensure that all products manufactured by Polo meets customer requirements. ESSENTIAL FUNCTIONS (Primary accountability for specific functions and results) Serves as a positive role model consistent with the companies corporate culture at all times. Proficient in use of QA manual and understanding of company quality requirements. Provides support to entire manufacturing team. Has final say in "accept" or "reject" decisions for manufactured product. Provides support to Maintenance and Engineering on developing shop-aids and fixtures. Provides support to PD group on developing master device testing procedures. Takes a pro active role with vendors,customers, quality representatives, and company personnel to discuss and resolve quality problems. Prepares for and represents the company during customer and 3rd-party audits. Writes or directs writing of company quality-related procedures as needed. Completes return goods report. Follows up with sales on necessary corrective action to be taken. Engages with Manufacturing in the corrective action process when necessary. Initiates and participates in the education process for all company associates. Prepares all necessary QA reports as requiredby customers and Director of Quality. Leads quality overview sessions for new associate and educates company associates on quality-related processes as appropriate. Participates in safe practices and good housekeeping. Travels to other plants, corporate meetings and seminars, requiring being away from home several days at a time. ADDITIONAL RESPONSIBILITIES (Not essential & could be performed by others, if necessary) Other duties as assigned. Ensures that external and internal customers' needs are met. POSITION REQUIREMENTS To perform at a proficient level and to be fully qualified, a person would be expected to have: Education: High School diploma or equivalent. Management and Quality Seminar training (minimum required) (both in house and outside). Prefer two (2) years technical degree in related field. Experience: Five (5) years applied experience. 5-7 years experiencein a supervisory (minimum required) capacity suitable equivalent for above education. Knowledge/Skills/Abilities (minimum required): 1.Effective human relation skills. Mathematical skills, use of general measuring tools, calipers,tape measures, and gauges. Ability to delegate. Good communication skills both oral and written. Ability to train associates technically in areas supervised. Problem solving and documentation. Motivational skills. Sensitive to ergonomic issues (good work habits). Skill in use of general office equipment. Dexterity and preciseness required to operate gauges and test equipment. Knowledge of QA manual and company quality requirements. Ability to establish methods for using statistical analysis, precision measurements, and process capability studies. Organized, responsible, punctual, and self-disciplined. Ability to communicate with associates and other business contacts in a courteous and professional manner. Ability to find problems, looks for cause or effect,and finds solutions. Follow oral and written instructions. Ability to prioritize work, meets deadlines, and performs accurately. Physical Requirements: Close visual work on the computerfor long periods of time. Ability to read, write, and communicate 100% of the time via phone, e-mail or in person to internal and external customers. Moves frequently about the facility walking, bending, climbing, and reaching. Able to remain in a stationary position standing or sitting 50% of the time. Occasionally lifts/and or carries objectsabout the facility up to 35 lbs. or with the proper equipment. Work Environment: Typical manufacturing environment, exposed to noise, constant motion, odors and variation in temperature.