QA Manager

Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country

United States

Shift

1st

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors.

Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

Responsible for overseeing the day-to day activities of the complaint team, works to assure timely case/complaint review and assignment. Responsible for managing the escalation process of potentially reportable complaints with attention to country specific reporting timeliness The QA Manager works with cross functional teams to support complaint escalations, investigations and field actions.

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 com plaints 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.
• 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 remediate 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 reporting as necessary
• Responsible for gathering complaint and RAW data for Post Market Surveillance and updating the RA reports including assessing newly identified risks.
• Follows regulatory requirements for complaint management.
• Establish and maintain 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.

Networking/Key relationships

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

Minimum Knowledge & Experience for the position:

• 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.

Skills & Capabilities:

• 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 analyst to complete tasks and project on time
• Must possess strong investigational skills to determine root cause, identify and implement effective corrective…