Overview
Werfen
Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. 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.
Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.
Job Summary:
Responsible for assuring timely case/complaint review and assignment. Responsible for assuring the escalation of potentially reportable complaints with attention to country specific reporting timelines. Responsible for reviewing complaints for accuracy and timely risk review. Responsible for monitoring the inquiry system. Responsible for assuring streamlined and efficient systems for complaint resolution. Responsible for product family specific systems and documentation which contribute to an effective complaint system compliant with FDA, ISO and Worldwide standards.
Responsibilities
Essential Functions:
- Ensures that all potentially reportable complaints are reviewed, escalated and overall managed in a timely and efficient manner
- Ensures timely and complete review of complaints for potentially reportable events
- Compiles and sends weekly potentially reportable reports to Management for review.
- Ensures timely and complete review of all complaints
- Reviews inquiries for potentially reportable complaints
- The lead for the product specific RAW process including creating RAW lines for new failures, reviewing and updating existing RAW lines and completion of RAW review and sign off.
- Chairing meetings and providing guidance and direction to the RAW team.
- Trains and develops subordinates, as appropriate, to achieve duties and responsibilities.
- Escalates relevant information on product complaints to appropriate product management as necessary.
- Coordinates and/or attends meetings with appropriate departments for specific customer complaint issues, determination and resolution of root causes for complaints.
- Generates manufacturing complaint tracking reports as needed.
- Performs other related duties as assigned.
- Analyze post market data for trend analysis and possible RAW review.
- 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.
- Follows regulatory requirements for complaint management.
Qualifications
Additional Skills & Capabilities:
- Familiar with FDA, ISO and Worldwide standards & regulations
- Knowledge of Medical Device or IVD regulations and quality systems related to complaints, risk, statistical techniques and good lab practices from a data collection aspect
- Risk Management
- Excellent written and oral communication skills
- Ability to analyze and trend data
Werfen People Manager Competencies:
The following competencies form part of the competency model for People Manager at Werfen and form part of our mindset around People Management and Leadership. We expect all People Managers of Werfen not only to demonstrate, but also to constantly continue to develop, the following competencies:
Building Talent:
- Planning and supporting the development of individuals’ knowledge, skills, and abilities so that they can fulfill current or future job responsibilities more effectively.
Customer Focus:
- Ensuring that the internal or external customer’s perspective is a driving force behind strategic priorities, business decisions, organizational processes, and individual activities, crafting and implementing service practices that meet customers’ and own organization’s needs; promoting and operationalizing customer service as a value.
Decision Making:
- Identifying and understanding problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints and optimizes probable consequences.
Driving for Results:
- Setting high goals for personal and group accomplishment; using measurement methods to monitor progress toward goals; tenaciously working to meet or exceed goals while deriving satisfaction from that achievement and continuous improvement.
Driving Innovation:
- Creating an environment (culture) that inspires people to generate novel solutions with measurable value for existing and potential customers (internal or external) ; encouraging experimentation with new ways to solve work problems and seize opportunities that result in unique and differentiated solutions.
Emotional Intelligence Essentials:
- Establishing and sustaining trusting relationships by accurately perceiving and interpreting own and others’ emotions and behavior; leveraging insights to effectively manage own responses so that one’s behavior matches one’s values and delivers intended results.
Minimum Knowledge & Experience Required for the Position:
- Ten years (with a Bachelor’s) or seven years (with a Master’s) relevant experience
- Four years of supervisory or people management experience is preferred
- Bachelor’s degree in relevant field
International Mobility:
Travel Requirements:
If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.
www.werfen.com
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