Complaint Systems Investigator
As a Complaint Systems Investigator at CONMED, you will 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.
Work Experience: 2 years experience in pharmaceutical, medical device, chemical or related industry experience in production, quality or regulatory compliance preferred but not required.
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 preferred.
This position can be seated in either Largo, FL or Utica, NY
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, 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.
CONMED offers competitive compensation
Excellent healthcare including medical, dental, vision and prescription coverage
Short & long term disability plus life insurance -- cost paid fully by CONMED
Retirement Savings Plan (401K) -- company match dollar for dollar up to 7%
Employee stock purchase plan -- allows stock purchases at discounted price
Tuition assistance for undergraduate and graduate level courses
CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status
Conmed - Linvatec Corp