Job Summary Shape your future CONMED is committed to developing high quality, innovative medical device products to improve the quality of life for our customers around the globe. As a Complaint System Investigator your role will be to review, investigate and process domestic and international complaints for Medical Device Reporting (MDR) and International (Vigilance) Device reporting requirements based on FDA Regulations,and International [Medical Device Directive (MDD)] Device Reporting requirements. Duties and Responsibilities: Triage, review and manage the movement of all credit returns\/devices related to complaints as needed for further review, analysis and\/or root cause investigation. Initiate the investigation process by gathering sufficient documentation for risk assessments and investigations. Identify and notify appropriate personnel for conducting root cause investigation. Assist in determining the need for corrective\/preventive actions or other required actions. Provide technical support to investigation team and\/or product design teams. Maintain high level knowledge of products, service\/repair processes and manufacturing processes. Participate in internal\/external audits, corrective\/preventive action and product team meetings as required. Maintain working knowledge of domestic and international regulations or standards related to Quality System Regulations (QSR), International Standards Organization (ISO), Medical Device Directives (MDD) and other international country regulations and medical device\/adverse event reporting requirements. Perform training and instructional guidance for employees in complaint system handling, QSRs, ISO Quality Standards and other topics as required. Ensure accurate complaint\/return data integrity to facilitate trending of complaints and service issues. This position can be seated in either Largo, FL or Utica, NY Qualifications Leave your footprint Minimum of 6 years experience in pharmaceutical, medical device, chemical or related industry experience in production, quality or regulatory compliance. BS degree in engineering, chemistry, sciences or equivalent experience in quality or regulatory industry. Basic knowledge of GMP\/QSR regulations and knowledge of MDR reporting requirement desirable. Strong working knowledge of QSRs, European Union Directives, ISO 13485 and related International Medical Device regulations. Benefits Be rewarded CONMED offers competitive compensation Excellent healthcare including medical, dental, vision and prescription coverage. Short & long term disability plus life insurance \u2013 cost paid fully by CONMED Retirement Savings Plan (401K) \u2013 company match dollar for dollar up to 7% Employee stock purchase plan \u2013 allows stock purchases at discounted price. Tuition assistance for undergraduate and graduate level courses. About CONMED Get In CONMED Corporation is a progressive, global medical device company. Through thoughtful leadership, innovation and team work, we are changing the future of medicine. Our 3,500 employees worldwide make meaningful contributions, positively impact the business, and advance in their careers as our company and product portfolio grows. We are a leader in Orthopedics, General Surgery, Gynecology, Gastroenterology, Pulmonology, and Anesthesiology and our employees enjoy challenging and diverse job opportunities across these varied specializations. We are headquartered in upstate New York with additional domestic facilities in FL, CA, MA, NJ, CO, and GA. We have an international presence in more than 20 locations throughout Europe, Australia, Latin America, Asia, North America, and the Middle East.