About
Responsibilities
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.
Networking / Key Relationships
Medical Affairs
R&D
Regulatory Affairs
IT / Cybersecurity
Global Affiliates
Operations
Other technology centers
Qualifications 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 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.
Travel requirements : N / A
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
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. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance.
We operate directly in over 30 countries, and in more than territories through distributors. Annual revenue is approximately $2 billion and more than 7, employees around the world comprise our Werfen
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Languages
- English
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