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CONMED Corporation · 17 hours ago

Investigator Complaint Systems

Largo, FL

Full-time

Onsite

Entry, Mid Level

2+ years exp

CONMED Corporation is a leader in medical technology, committed to empowering healthcare providers worldwide. The Complaint Systems Investigator will review, investigate, and process complaints for Medical Device Reporting, ensuring compliance with FDA regulations and international reporting requirements.

Information TechnologyMedicalMedical Device

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

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)/Medical Device Regulation (MDR)] and other international country regulations and medical device/adverse event reporting requirements

Maintain high level knowledge of products, service/repair processes and manufacturing processes

Qualification

Quality System Regulations (QSR)ISO 13485Medical Device ReportingRegulatory complianceRoot cause investigationTechnical supportDocumentation gatheringAudit participation

Required

Associate degree in engineering, chemistry, or other related discipline

Preferred

Bachelor's degree in engineering, chemistry, or other related discipline

2 years of experience in quality or regulatory industry

Experience in production, quality or regulatory compliance or equivalent internship(s)

Experience in pharmaceutical, medical device, chemical or related industry

Working knowledge of QSRs, European Union Directives, ISO 13485 and related International Medical Device regulations

Benefits

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) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period

Employee Stock Purchase Plan -- allows stock purchases at discounted price

Tuition assistance for undergraduate and graduate level courses

Company

CONMED Corporation

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CONMED is a global medical technology company that specializes in the development and sale of surgical and patient monitoring products and services that allow our physician customers to deliver high quality care and as a result, enhanced clinical outcomes for their patients.

Founded in 1970

Utica, New York, USA

1001-5000 employees