Manager, Product Complaint & Support

• Accountable for the timely and accurate completion of quality related inquiry activities through the Product Complaint & Support(PCS) team. Ensure that complaints are captured in their entirety and all information is captured in its entirety prior to complaint closure.
• Develop and implement the staffing strategy and operational readiness plan to ensure the Transfusion & Cellular Therapeies and Infusion System complaint management commitments are met.
• Directly interface with key business leaders(Sales, Implementation, Quality, etc.) to ensure alignment between business needs/growth and balancing the operational requirements
• Responsible for tracking and analyzing metrics and key performance indicators related to Quality Complaints to ensure compliance as well as workload and capacity management.
• Identify, develop, and implement process improvement opportunities to enhance service to customers and aid the operation in achieving the Field Services & Support, MedTech, and Fresenius Kabi vision and goals.
• Oversee efforts to implement and optimize the S4Hana solution across MedTech complaint management including a solution for an end to end solution to capture Infusion System device complaints, returns, and reissue.
• Overall responsibility for additional system management(ex.Synergy, Product Complaint Web Portal, etc.) efforts including content, maintenance, user testing, deployment support, rollout of technical fixes, implementation of new functionality & complaint reporting forms, and any associated training related to systems used by the PCS team.
• Represent Product Complaint & Support in cross functional projects and issue resolution (Post Market Quality Assurance, Supply Chain, Customer Master, Material Master, Plants, Customer Service, Marketing, etc.).
• Overall responsibility for the creation, management of, and maintenance of all Product Complaint & Support documentation including Standard Operating Procedures and Work Instruction
• Ensure a robust audit program is developed and deployed to ensure regulatory compliance and customer expectations are met and results are captured via scorecards and reviewed organizationally and at the employee level.
• Manage the creation and management of the Product Complaint & Support new hire training classes and ensure on-going training when processes are modified, or retraining is needed. Support the ongoing efforts to evaluate and select training and development solutions for the organization such as external training providers, certifications, etc.
• Liaison between Post Market Quality Assurance and the Field Service & Support organization to ensure strategic planning is aligned across the organizations, reviews occur on complaint trends, investigation timelines are monitored, and process changes or improvements are implemented together.
• Oversee the facilitation of Quarterly Quality Reviews with Key Customers such as Biolife.
• Actively participate in the Weekly Ivenix Compliance Team meetings and ensure key follow up actions are taken.
• Drive collaboration between Product Complaint & Support, Warrendale Depot, and Customer Service teams to manage Ivenix device returns and ensure accurate documentation for quality reporting.
• Fosters collaboration and support various FK internal departments (Executive, Legal, IT, Customer Service, Marketing, R&D, etc), as well as with external customers such as Blood and Plasma strategic accounts.
• Actively participate in special projects as assigned and able to solve complex problems with innovative solutions.

All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

• Bachelor's degree required
• Minimum of 5 years related work experience (medical device experience preferred).Knowledge of FDA Quality Systems and Medical Device Reporting regulations (21 CFR 803, 820 & 211; Part 11)
• Ability to prioritize multiple risk projects to ensure compliance with regulations and standard operating procedures.
• Excellent customer service, collaboration, teamwork, and communication skills (verbal & written) and proven presentation skills.
• Ability to work independently, manage multiple priorities in a matrix environment, support complex team issues and team dynamics, and make difficult decisions.
• Demonstrated leadership in effectively managing a team of employees towards common goals, ensuring accuracy in the end results, and able to coach, mentor and provide effective feedback.
• Advanced analytical skills with a strong attention to detail and strong organizational skills.
• Strong ability to identify abnormalities/potential problematic areas and provide solutions.
• Flexibility to work on new products/assignments.
• Ability to work cross functionally to drive improved business processes and results.
• Process focused with proven ability to think innovatively and strategically.
• Must have advanced system skills in Microsoft Office applications(ex. Excel, Word, PowerPoint, etc.), ERP systems (SAP required), SharePoint administration, Salesforce.com preferred), data visualization software(preferably Qlik Sense), and other database concepts highly preferred.
• Strong interpersonal skills and the ability to work with cross-functional teams and build partnerships with internal and external parties.
• Self-motivated and quick learner.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.