QA Manager I

Werfen • Bedford, MA

89d

About The Position

The QA Manager is responsible for overseeing the day-to-day activities of the complaint team, ensuring timely case and complaint review and assignment. This role involves managing the escalation process of potentially reportable complaints with a focus on country-specific reporting timeliness. The QA Manager collaborates with cross-functional teams to support complaint escalations, investigations, and field actions.

Requirements

• Bachelor's degree in relevant field (i.e. Life Science, Biochemistry, Engineering or similar).
• 10 years of relevant experience with a Bachelor's degree or 8 years with a Master's degree.
• 5 years of supervisory or people management experience.
• Strong knowledge of FDA, Medical Device and IVD regulations and quality systems related to complaints.
• Strong investigational skills to determine root cause and implement effective corrective actions.
• Demonstrated ability to organize complex work assignments and oversee analysts to complete tasks and projects on time.
• 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.

Responsibilities

• Manages the complaint team to ensure accuracy and timely risk review and thorough complaint investigations are completed.
• Responsible for product family specific systems and documentation which contribute to an effective complaint system compliant with FDA, ISO and Worldwide standards.
• Ensures timely and thorough review of all complaints and inquiries, prioritizing potentially reportable events.
• Escalate any potentially reportable complaint or inquiry, communicates with the cross functional 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.
• Chairs meetings and provides guidance and direction to the RAW team.
• Trains and develops subordinates, as appropriate, to achieve duties and responsibilities.
• Coordinates monthly complaint trend review meetings with appropriate departments and ensures that escalations, investigations and CAPA Actions are taken to remediate negative trends or specific customer complaint issues.
• Determines and resolves root causes for complaints.
• Provides complaint inputs to the post market surveillance reporting process.
• Maintains Complaint KPI data and reporting as necessary.
• Gathers complaint and RAW data for Post Market Surveillance and updates the RA reports including assessing newly identified risks.
• Follows regulatory requirements for complaint management.
• Establishes and maintains a system to review literature and social media for complaints.
• Manages tasks supporting complaint investigations, including returned parts and external assignments.
• Supports investigation activities and provides guidance for resolving product malfunctions.
• Performs other related duties as assigned.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees