Investigator Complaint Systems

Largo, MD - USA

Monthly Salary: Not Disclosed

Posted on: 22 hours ago

Vacancies: 1 Vacancy

Job Summary

CONMED is a leader in medical technology. We empower healthcare providers worldwide to deliver exceptional outcomes for patients. If you are committed to making a difference and delivering exceptional results youll find a group of people here that shares your passion for meaningful work. Youll be supported by a leadership team that promotes engagement through professional development new challenges and growth opportunities over the course of your career. Come inspire us through your dedication creativity and exceptional performance - well do the same for you!

The Complaint Systems Investigator 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)/Medical Device Regulation (MDR) Device Reporting requirements.

Key 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.
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.

Job Requirements:

Associate degree in engineering chemistry or other related discipline. Bachelors degree in engineering chemistry or other related discipline preferred.
2 years of experience in quality or regulatory industry preferred.
Experience in production quality or regulatory compliance or equivalent internship(s) preferred.
Experience in pharmaceutical medical device chemical or related industry preferred.
Working knowledge of QSRs European Union Directives ISO 13485 and related International Medical Device regulations preferred.

ADA Disclosure:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Benefits:

CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.

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

Know someone at CONMED Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!

CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.

Colorado Residents: In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

If you feel you need a reasonable accommodation pursuant to the ADA you are encouraged to contact us at option #5.