Supplier Quality Manager

WORK SHIFT DAY (United States of America) SUMMARY OF DUTIES This position is responsible to establish and maintain procedures ensuring that all purchased and received product and services (outsourced, subcontractors and consultants) conform to specified requirements. This position is responsible to ensure that process validations, test method validation, specifications are conforming to requirements. ESSENTIAL FUNCTIONS PERFORMED Establishes and maintains the requirements, including quality requirements, which must be met by suppliers, contractors or consultants. Ensures that Merit documentation sufficiently describes the product and/or services to be supplied and meets the requirements for approval of product; inspection / acceptance procedures, processes and equipment; qualification of personnel and quality management system requirements are understood by suppliers and Merit personnel, as appropriate. Establishes the evaluation, selection and re‑evaluation processes needed to document the ability of the suppliers, contractors or consultants to meet specified requirements. Defines the type and extent of control to be exercised over the product, services, suppliers and consultants based on risk to the finished product and on the supplier evaluation results. Reviews and analyzes data related to supplier qualification and performance to specified requirements. Provide reports to management, as appropriate. Maintains records of inspections or other activities demonstrating that the specified requirements have been met. Ensures purchasing documents include, where appropriate, an agreement that the supplier shall notify Merit of any changes in the product or services. Ensures that changes do not affect the quality of the finished device or its legally marketed regulatory status. Ensures records of corrective and/or preventive actions arising from the evaluation process and/or supplier approval documentation are maintained and reviewed by management. Identify areas of improvement and facilitate process improvement, as appropriate. Ensure remediation activities are completed to schedule which include but are not limited to process validation, test method validation, and specification updates throughout the supply base. Coordinates supplier related problems with Purchasing, Engineering and IQA, as appropriate. Ensures that supplier related issues are addressed by Merit’s risk management process. Provides input to and manages the department budget. Provides adequate qualified resources to meet departmental objectives and support operations and quality needs. Performs other related duties and tasks as required. ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS Lifting – Not to exceed 50 lbs. – local practice may apply. Writing Sitting Standing Bending Vision Color perception Depth perception Reading Field of vision/peripheral Fine motor skills SUMMARY OF MINIMUM QUALIFICATIONS Education and/or experience equivalent to a Bachelor’s Degree in Engineering or related field. A minimum of six years of supplier quality and risk management (ISO 14971) experience. Excellent interpersonal, and oral and written communication skills. Problem solving and conflict management skills. Excellent organizational skills and the ability to work under strict time constraints. Strong analytical skills and attention to detail. Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs. COMPETENCIES Supplier quality metrics/agreements/risk mitigation program/reports Supplier approval process Continuous improvement Computer skills COMMENTS Infectious Control Risk Category III: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure. Benefits Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights Medical/Dental & Other Insurances (eligible the first of month after 30 days) Low Cost Onsite Medical Clinic Two (2) Onsite Cafeterias Employee Garden | Gardening Classes 3 Weeks’ Vacation | 1 Week Sick-Time | Paid Holidays 401K | Health Savings Account Military Veterans are encouraged to Apply. Merit is a proud Utah Patriot Partner committed to hiring our Veterans. #J-18808-Ljbffr