Global Product Surveillance Quality Associate II

Job Description

Job Summary:

• 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.

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.

Education and/or Experience:

• Include the education and experience that is necessary to perform the job satisfactorily. Bachelors degree required. 2-5 years relevant work experience in cGMP related industry or in a clinical setting.

Knowledge, Skills, and/or Abilities:

• 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.