Quality Complaints Manager
ProClinical, in support of our client, are seeking an individual to fill the role of Quality Complaints Manager, based in Boston, MA. The successful candidate will This position is primarily responsible for ensuring timely medical device reporting by assessing complaints against reporting requirements and facilitating any required further investigation.
- Provide review of complaint to ensure all information needed for reporting/MDRs is present; determine if further investigation is needed and track investigation to conclusion.
- Write MDRs/MIR/Vigilance reports and submit to the necessary authorities as required.
- Monitors and improves tracking/control systems for medical device reporting
- Investigates and prepares response to address Competent Authority inquiries and provide follow-up
- Work with a variety of diverse persons within and outside the company to gather additional information required for complaint investigation.
- Own the adverse event reporting process for complaints.
- Ensure all required global adverse event reports are complete and communicated within required time frames.
- Ensure that the appropriate procedures and processes are followed in order to be compliant, and areas are fully prepared for the Notified Body Audits and any FDA inspections.
- Evaluate documentation for completeness and consistency and assign additional actions as necessary to close the complaint file.
- Approve final complaint file for closure after all applicable actions are completed.
- Escalate complaints to the Regulatory Compliance Engineer when new failure modes are encountered. Escalate complaints to the Head of Quality group as required
- Participate in process improvement activities to continuously improve process effectiveness
- Aid the VP of Quality in ensuring quality objectives, regulatory requirement, and customer requirements are met.
Skills and Qualifications
- 5-7 years of related experience with a BA degree, or 2-5 years' experience with an MA.
- Demonstrated knowledge of scientific principles in a GMP/GLP regulated environment.
- Quality assurance experience preferred.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Paul Sinclair at (+1) 628-225-1681 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
£0.00 - £45000.00 per annum
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