CONMED offers more than 10,000 medical devices to healthcare providers around the world. As a complaints investigator for 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. You will be a vital part of leveraging customer feedback for improving the design of current and new products.
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 Requirements: Minimum of 2 years’ experience in pharmaceutical, medical device, chemical or related industry experience in production, quality or regulatory compliance.
Education Requirements: Associates degree in technical, engineering, chemistry, sciences plus 2 years of experience in quality or regulatory industry, or bachelor’s degree in technical, engineering, chemistry or sciences.
Knowledge Requirements:
- 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.
Benefits:
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, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-325-5900 option #3.
Source: Indeed.com
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