Customer Quality Specialist
Proclinical is currently recruiting for a Customer Quality Specialist with our client located in Santa Ana, CA. Successful candidate will comply and maintain and process complaint records, complete review and process all potentially reportable events and determine whether an MDR and/or Vigilance report is required based on the information contained in the complaint record.
- Process complaint files per internal procedures and external requirements.
- Ensure timely filing of reportable events with regulatory agencies worldwide.
- Prepare and submit initial and final submissions as required by regulations, including the documentation of the information reviewed and the rationale for filing/not filing a report.
- Work with the Regional Complaint Handling Units and conduct follow up activities in order to gather the necessary information for the initial and supplemental reports.
- Ensure adherence to compliance requirements and policies outlined for marketing companies, external manufacturers, packaging and labeling, product testing, returned goods, product complaints and recalls.
- Report any nonconformance to the quality assurance director and supply chain.
- Perform other duties assigned as needed.
Skills and Requirements:
- Bachelor's degree in Physical Science/Engineering or 1-2 years of combined experience in related area.
- Direct experience in Complaint Handling and Medical Event reportability within medical device or similar industry preferred (complaint handling is a must for exp).
- Experience with MDR drafting preferred.
- Hands-on experience using Microsoft Excel, Outlook and Word.
- Hands-on experience using Adobe Professional.
- Good analytical skills.
- Excellent interpersonal skills.
- Excellent communications skills.
- Excellent customer service skills.
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 Samantha Reader at (+1) 267-983-0134 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.
Proclinical Staffing is an equal opportunity employer.