QA Complaint Analyst Group Lead I

Bedford, MA, United States

Overview 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 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:

Has oversight for the complaint team and process, including training, assignment of tasks, guidance on investigational plan design, execution, and results.

Drives investigation activities and provides guidance for effective complaint analysis for resolution of product malfunction concerns to meet our goals.

Reviews complaint trend data and ensures that escalation occurs as necessary.

Reviews inquiries for potentially reportable complaints

Ensures timely and complete review of all complaints; including all potentially reportable events are prioritized.

Chairing meetings and providing guidance and direction to the Risk Analysis team.

Provides support and back up as needed for the product specific Risk Management meeting.

Is responsible for the review of complaints for the timely submission and complete documentation for the Risk Management process.

Coordinates and/or attends meetings with appropriate departments for specific customer complaint issues, determination and resolution of root causes for complaints.

Communicates to the supervisor updates that need escalation or priority discussion as well as updates on the overall status of complaint activities.

Ensures regulatory requirements for complaint management are followed.

Performs other related duties as assigned.

QualificationsAdditional Skills & Capabilities: Strong customer focus and can-do attitude.

Familiar with FDA, ISO and Worldwide standards & regulations

Strong 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 process knowledge.

Excellent written and oral communication skills

Ability to analyze and trend data and communicate concerns as needed.

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: Bachelor's degree in relevant field.

Eight years (with a Bachelor's) or five years (with a Master's) relevant experience.

Two years of supervisory or people management experience is preferred.

International Mobility: Required: No

Travel Requirements: N/A

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 [email protected] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com

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