Werfen is hiring a QA Manager I to oversee the daily operations of our complaint handling team. You will be responsible for ensuring timely case review and assignment, managing the escalation process for potentially reportable complaints, and collaborating cross-functionally to support investigations and field actions.
What You'll Do
- Manage the complaint team to ensure accurate, timely risk reviews, and thorough investigations.
- Maintain product family specific systems and documentation for an effective complaint system compliant with FDA, ISO, and worldwide standards.
- Escalate potentially reportable complaints, communicate with cross-functional teams and management, and drive the post-market Risk Analysis Worksheet (RAW) process.
- Communicate updates on escalations, priorities, and complaint status to leadership.
- Chair meetings and provide guidance to the RAW team.
- Train and develop subordinates.
- Coordinate monthly complaint trend review meetings and ensure escalations, investigations, and CAPA actions are taken to remediate negative trends.
- Provide complaint inputs to the post market surveillance reporting process.
- Maintain Complaint KPI data and reporting.
- Gather complaint and RAW data for Post Market Surveillance and update RA reports, including assessing newly identified risks.
- Follow regulatory requirements for complaint management.
- Establish and maintain a system to review literature and social media for complaints.
- Manage tasks supporting complaint investigations, including returned parts and external assignments.
- Support investigation activities and provide guidance for resolving product malfunctions.
What We're Looking For
- Bachelor's degree in a relevant field such as Life Science, Biochemistry, Engineering, or similar.
- 10 years of relevant experience with a Bachelor's, 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, quality systems related to complaints, and statistical techniques.
- Demonstrated ability to organize complex work assignments and oversee analysts to complete tasks and projects on time.
- Strong investigational skills to determine root cause 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.
Team & Environment
You will work with cross-functional teams including Medical Affairs, R&D, Regulatory Affairs, IT/Cybersecurity, Global Affiliates, Operations, and other technology centers.
Benefits & Compensation
- Medical, dental, and vision insurance.
- 401k plan retirement benefits with an employer match.
- Paid vacation and sick leave.
- Eligible for a performance-based bonus.
- Compensation range: $140,000 to $160,000.
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law.
