QA Specialist – Complaint Handling

About Us:

How many companies can say they've been in business for over 179 years?!

Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements.

ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change.

We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology.

We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!

What's the role?

To assist in maintaining Quality Assurance and Control practices in adherence to the Food and Drug Administration (FDA) regulations for the Quality System Regulation and for ISO 13485 standards, the QA Specialist is responsible for managing complaint handling, returned goods tracking and reporting requirements.

The QA Specialist will be responsible for working with the Engineering, Manufacturing and Quality Assurance teams coordinating activities required for investigations including failure analysis, nonconformance and CAPA related to complaints.

The position requires reporting returns to regulatory agencies as required and close investigations within appropriate timeframes.

Sound Interesting?

Here's what you'll do:


* Manage the end-to-end product complaint process, ensuring timely and compliant handling from intake through closure.


* Evaluate, investigate, and resolve customer complaints in accordance with internal procedures and applicable regulations, including ISO 13485, FDA 21 CFR 820, and MDSAP requirements.


* Conduct and coordinate root cause investigations by gathering data, performing product evaluations, and collaborating with cross-functional teams.


* Maintain complete, accurate, and compliant complaint records, documenting investigation results, conclusions, and supporting rationale.


* Partner with Manufacturing, R&D, Regulatory Affairs, Quality, and Supply Chain teams to drive effective complaint resolution.


* Communicate with customers, distributors, and internal stakeholders to obtain information and provide updates throughout the investigation process.


* Support escalation activities for potential safety concerns or systemic quality issues.


* Coordinate returned product evaluations, ensuring traceability and proper documentation.


* Maintain complaint files and data within the complaint management system in accordance with Good Documentation Practices (GDP).


* Analyze complaint trends and perform statistical evaluations to identify recurring issues, emerging risks, and areas for improvement.


* Prepare and present complaint trend reports to Quality and Management Review teams and provide input for CAPA activities and risk assessment...