Quality Systems Specialist - Complaints

Responsible for investigating Customer Quality Complaints, coordinating the Annual Product Quality Reports (APQR), and Metrics Reporting. Other functional responsibilities may include authoring and revising Quality System Documentation and trending and evaluating Product Quality.

Key Responsibilities/Essential Functions

• Initiates product quality complaints in our Quality Management System (QMS).
• Performs product quality complaint investigations and assigns investigation tasks to technical functions as needed.
• Collaborates with Technical Support, Engineering, Analytical Laboratories, Manufacturing, Validation, Customer Service and Regulatory Affairs groups to ensure timely complaint investigations and closure.
• Evaluates scientific data for trends, drives investigations, and proposes the need for changes to manufacturing or control procedures.
• Documents complaint investigation activities and summary. Responsible for timely closure of complaints.
• Recommends the need for further investigation and escalation to CAPA. Drives closure of associated investigation(s) and CAPA(s).
• Performs routine trending of product complaints and evaluating trends, escalating issues as necessary.
• Responsible for Annual Product Quality Reports (APQR). Collaborates with internal stakeholders on data collection and ensures timely completion of reports.
• Responsible for collecting and reporting metrics as required per internal procedures and as requested by leadership.
• Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety and environmental hazards.
• Other duties as assigned.

Basic Qualifications

• Bachelor of Science in a technical discipline or equivalent combination of education and experience.
• Minimum of 5 years of experience in quality and manufacturing in the pharmaceutical, medical device, or biological industries.
• Experienced in investigating and documenting Customer Product Quality Complaints, effectively communicating in written form, and collaborating with various internal and external business partners in problem resolution.
• Experienced with metrics reporting.
• Organized, detail oriented and self-motivated.

Exposure to Annual Product Quality Reviews preferred