Global Product Surveillance Quality Associate II

Target Pay Rate: 24/hr **salary will be commensurate with experience

Job Description:

This section focuses on the main purpose of the job in one to four sentences. This position is responsible for complaint handling, will triage incoming complaints for the assigned team, and will process all levels of complaints without supervision.
Essential Duties and Responsibilities: This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.

• Triage incoming complaints from internal or external customers to determine next steps in the process based on level of risk.
• Collect necessary complaint information for investigations.
• Determine reportability of a complaint.
• Respond to customer complaints (written or verbal) and write technical investigation response letters.
• Participate in continuous improvement activities and projects (ie: CAPA, Product Improvement Teams).
• May lead projects as assigned by management.
• May have technical approver responsibilities.
• Manage workflow; identify and escalate issues.
• Participate in mentoring and training of the Product Surveillance team.
• Ability to perform all duties required of previous levels.

Qualifications:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• List knowledge, skills, and/or abilities required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• Strong knowledge of the FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 806, 820, and 211).
• Understanding of the products intended use and manufacturing process of assigned products.
• Strong technical writing skills, able to review complaint investigations and write customer response letters.
• Readily accepting of assignments to new/ different products.
• Ability to prioritize multiple risk projects to ensure compliance with regulations and standard operating procedures.
• Excellent written/verbal communication and organizational skills.
• Ability to make independent decisions with minimum oversight.
• Strong problem solving and analytical skills.
• Knowledge and application of computer systems for word processing, reporting, data analysis and complaint management.

Education and/or Experience:

• Bachelors degree required.
• 2-5 years relevant work experience in cGMP related industry or in a clinical setting.