Field Assurance Assistance Manager-Medical Device

Secure your future in the field of Medical Device! Exceptional job security and advancement!! Major leader in the stable and rapidly growing medical device industry is searching for a Field Assurance Assistant Manager with specific background experience in medical device manufacturing, preferred. Desirable location, competitive salary and great benefits !!! Supervise the Field Assurance personnel and provide a high degree of confidence that all product complaints received on products manufactured and/or marketed are documented and maintained in compliance to applicable Quality Systems regulations, ISO 13485 requirements, FDA regulations and Corporate, Division and International policies and procedures. Maintain customer goodwill through efficient and effective communications and follow-up on customer concerns. Assist with responding to FDA inquiries and with preparing and submitting Medical Device and Baseline Reports to FDA for both domestic and international markets. Coordinate the review, investigation and corrective actions of product complaints with manufacturing source Quality Assurance personnel to ensure consistency and attention to detail in performing and documenting complaint evaluations. Ensure that upper management is informed of potential recall situations and complaint trends in the absence of the Field Assurance Manager. Interpret corporate policies and other regulatory requirements as to how they relate to Field Assurance and prepare, implement and train on Divisional procedures for conformance. Provide support to project teams in preparing DFMEAs, establish complaint handling, MDR reporting and servicing responsibilities via contracts, reviewing labeling and complaint history on similar products, and monitoring market tests and quality issues found during clinical studies. Function as Product Litigation Coordinator and interact with Corporate Legal in responding to litigation requests. Interact with international facilities with reporting responsibilities establishing standardization of complaint handling and MDR/vigilance compliance. Serve as back-up to Manager, Field Assurance in manager's absence. RequirementsProficient in the use of a personal computer. Strong interpersonal skills required in the areas of verbal and written communications, customer focus, service to internal customers, telephone manner, professionalism, coaching, influencing and team building. Strong listening and assessment skills. Strong questioning and problem solving skills. Detail oriented. Must be able to manage people and control stressful situations. Must possess a professional image and demonstrate work maturity. Bachelor's Degree in Science, preferred. TO BE CONSIDERED, PLEASE E-MAIL YOUR RESUME TO US IN WORD DOC FORMAT. MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: Statewide, GA JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee SALARY: 59,000.00 - 65,000.00 USD /year7% BONUS JOB REFCODE: 2211 COMPANY: Alliance Executive Search, LLC PHONE: 919-554-0783