Quality Specialist

Description

The Quality Specialist will be responsible for managing the end-to-end lifecycle of product complaints, including complaint intake, investigation, troubleshooting, testing, documentation, and reporting. This individual will review complaint information, investigate potential root causes, analyze data and trends, maintain accurate records, and ensure all documentation is completed in accordance with established quality and regulatory procedures.

Additional responsibilities include communicating with customers as needed throughout the complaint resolution process, maintaining audit-ready documentation, supporting corrective and preventive actions (CAPA), identifying quality trends, and collaborating with cross-functional teams to support continuous improvement initiatives.

Requirements

2-4 years of experience in Quality, product complaints, investigations, analytics, customer service, or a related function within an FDA-regulated environment

Bachelor's degree preferred

Working knowledge of FDA quality regulations and Quality Management Systems (QMS)

Knowledge of ISO 13485 and ISO 14971 preferred

Experience handling complaint investigations and performing root cause analysis

Strong documentation and technical writing skills

Strong analytical skills with the ability to review data, identify patterns, and communicate findings

Advanced Excel skills and proficiency with Microsoft Office

Strong customer service and interpersonal communication skills

Ability to learn new systems, processes, and technical information quickly

Strong organizational skills and attention to detail

Ability to manage competing priorities in a high-volume, fast-paced environment

Team-oriented while also comfortable working independently and taking initiative

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All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit  for more information.

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