Medical Device Complaint Handling Specialist III

at  Thermo Fisher Scientific

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

EDUCATION

• Bachelor’s degree in a relevant field, such as biomedical engineering, life sciences, or a related field required.

EXPERIENCE

• 3 - 5+ years experience in an FDA regulated environment (drugs, biologics, medical devices or related products)
• Detailed knowledge of ISO 13485 and GMP regulations which govern a medical device and diagnostics manufacturing.
• Strong analytical and problem-solving skills required.
• Tracking and trending tools and reporting techniques

KNOWLEDGE, SKILLS, ABILITIES

• Able to create presentations, work with spreadsheets, prepare reports and write procedures utilizing MS Word, Excel and PowerPoint software applications.
• Lead meetings and obtain consensus among cross functional teams
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively in a team environment.
• Attention to detail and ability to manage multiple tasks simultaneously.
• Exercise independent discretion and judgment in execution of duties.

The duties and responsibilities include, but are not limited to, the following:

• Receive and review complaints related to medical devices.
• Investigate complaints by gathering relevant information, analyzing data, and conducting root cause analysis.
• Ensure customer complaint investigations are complete, accurate and closed in a timely manner; includes meeting regulatory requirements
• Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Product Development, to resolve complaints.
• Connect with customers to address concerns and provide updates on complaint resolution.
• Supervise complaint trends and find opportunities for product improvement.
• Ensure compliance with applicable regulations and standards, such as FDA 21 CFR Part 820 and ISO 13485.
• Prepare for and participate in internal and external audits.
• Provides matrix/project leadership, training and guidance to junior team members.
• Ability to maintain accurate records
• Participation in cross-functional business process improvement activities as the need arises.

Keys to Success: