QA Manager I

• Manages the complaint team to ensure accuracy and timely risk review and thorough complaint investigations are completed.
• Responsible for product family specific sytems and documentation which contribute to an effective complaint system compliant with FDA, ISO and Worldwide standards.Ensures tlmely and thorough review of all com plaints and inquiries, prioritizing potentially reportable events.
• Escalate any potentially reportable complaint or inquiry, communicates with the crossfunctional team and management, drives the post market Risk Analysis Worksheet (RAW) process through completion.
• Communicates updates on escalations, priorities, and complaint status to leadership and in various meetings.
• Chairing meetings and providing guidance and direction to the RAW team.
• Trains and develops subordinates, as appropriate, to achieve duties and responsibilities
• Coordinates and monthly complaint trend review meetings with appropriate departments and ensures that escalations, investigations and CAPA Actions are taken to remedlate negative trends or for specific customer complaint issues, determination and resolution of root causes for complaints.
• Provide complaint inputs to the post market surveillance reporting process
• Responsible for maintaining Complaint KPI data and reportjng as necessary
• Responsible for gathering complaint and RAW data for Post Market Surveil lance and updating the RA reports including assessing newly identlfed risks.
• Follows regulatory requirements for complalnt management.
• Establish and maintain a system to review literature and social media for complaints.
• Manages tasks supporting complaint investigations, Including returned parts and external as signments.
• Supports investigation activities and provides guidance for resolving product malfunctions
• Performs other related duties as assigned.

• Medical Affairs
• R&D
• Regulatory Affairs
• IT /Cybersecurity
• Global Affiliates
• Operations
• Other technology centers

• Bachelor's degree in relevant field (i.e. Life Science, Biochemistry, Engineering or similar
• 10 years (with a Bachelor's) or 8 years (with a Master's) relevant experience.
• 5 years of supervisory or people management experience.

• Strong knowledge of FDA, Medical Device and IVD regulations and quality systems related to complaints, and statistical techniques and the ability to train others related to these requirements.
• Demonstrated ability to organize complex work assignments and oversee analyts to complete tasks and project on time
• Must possess strong investigational skills to determine root cause, identify and implement effective corrective actions
• Strong interpersonal communication skills
• Strong customer focus and continuous improvement mentality.
• Excellent written and oral communication skills
• Ability to drive Risk Management, escalation and complaint closure processes.
• Critical thinking skills, including the ability to analyze and trend data and communicate concerns as needed.

Werfen