Global Complaint Handling Specialist

As a Global Complaint Handling Specialist, you will be a valued team member of Global Quality Systems supporting Revvity global entities with Complaint Handling activities.

In this role you will provide day-to-day support Revvity Product Complaints Management Program. This role will effectively and efficiently process complaints on products (Life Science & Diagnostics), escalate safety and security concerns quickly, and meet regulatory reporting obligations.

You should be able to work both independently and in collaboration with other members of the Complaint Handling group on projects to produce deliverables in a timely manner.

The job described on this document requires that the employee occupying this position work in a flexible schedule to be able to assist other Revvity employees with different time zones.

Main responsibilities:

In the Complaint Handling Specialist s role, you will be responsible for the following: -

• Managing the day-to-day complaints processing, including receiving, documenting, evaluating, and coordinating investigations of customer complaints associated with Revvity products (Diagnostics & Life Science) in accordance with Revvity complaints management process and applicable regulations.
• Collaborating with a variety of diverse persons such as Site Quality, Engineers, Scientists, Clinical Specialists, Field Service Engineers, Professional Customers and Manufacturing personnel to facilitate the complaint investigation process globally.
• Evaluating complaints for device reporting to respective regulatory authority as per applicable regulations.
• Updating and maintaining complaint files in accordance with applicable procedure and international regulations prior to closing.
• Ensuring accuracy, completeness and consistency of documentation, follow-up, communication with respective departments, and timely closures of all complaints.
• Interfacing with customer service when necessary to obtain additional information to support complaint investigation and product returned for investigation.
• Providing input and support during escalation of safety and quality issues based on surveillance data.
• Following applicable complaint handling and reporting procedures.
• Tracking and trending customer complaints and periodically reporting on those results.
• Working with the Site Quality team to track and trend customer complaints.
• Attending team meetings focused on complaint handling and reporting.
• To support Quality Improvement Projects for data analysis
• Participating in projects as team member with specific identified deliverables.
• Providing support during internal and external audits. May be required as SME
• Creating and preparing neat and error-free SAP, LMS, Salesforce, SharePoint, Excel, etc. reports as needed for delivery. Compiling department metrics and report out to management.
• Performing a variety of tasks to support the short and long-term goals. Work with functional management to proactively look for continuous improvement for the quality organization and assist in training aspect of quality function.

Note: This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. The incumbent is expected to perform other duties necessary for the effective operation of the Global Quality Systems for Complaint Handling.

Required Competence

• Bachelor s degree in Life Sciences or Engineering or equivalent work experience
• 6+ years of relevant work experience in a similar industry; Medical Device, IVD, Pharmaceuticals, preferably with a regulated environment.
• Hands-on experience on SAP, Trackwise and any other complaint handling tool
• Well versed in complaint trend preparation with help of data analysis tool like Power BI and Spotfire
• Superior interpersonal, verbal, and written communication skills
• Actively works together with formal and informal team members to build relationships and achieve team goals
• Strong data analysis skills and proficiency in electronic data management systems
• Ability to take direction and multi-task in a fast-paced environment
• Exceptional organizational, negotiation, and problem-solving skills
• Proficient in MS Word, Excel, PowerPoint, Microsoft office.
• Ability to learn new computer applications such as SAP, LMS, PDM, Agile, and SharePoint.
• Strong Problem-Solving Skills, Teamwork, effective and consistent Leadership Ability, Reliable, responsible and dependable in fulfilling obligations.
• Ability to work with minimum supervision.
• Strong attention to detail and project management skills.
• Ability to work in a dynamic environment serving different audiences worldwide.
• Well-developed written, verbal, numerical reasoning, and analysis skills.

Ability to work in a matrixed organizational structure, developing strong relationships with multi-national business partners