Quality Assurance Specialist (Batch & Product Release)

Position Overview

We are seeking a detail-oriented Quality Assurance Specialist to support the final release of finished medical device products. In this role, you will review documentation to ensure accuracy, completeness, and regulatory compliance prior to product shipment. You will work closely with cross-functional teams to identify documentation errors, resolve non-conformances, and drive continuous quality improvement.

Responsibilities

• Review Device History Records (DHR) and job records (including instrument assembly and product jobs) for accuracy, completeness, and compliance.
• Support the final release of finished medical device products, verifying that all items meet established quality standards prior to shipment.
• Identify, document, and escalate documentation errors or quality issues in accordance with standard operating procedures.
• Collaborate with cross-functional teams to resolve quality non-conformances and support continuous process improvements.
• Operate effectively with minimal supervision, following established procedures and quality standards.

Requirements

• 0–2 years of experience in quality assurance, manufacturing, or technical documentation review.
• High School Diploma or equivalent required (Bachelor of Science degree preferred).
• Demonstrated ability to follow defined procedures and work independently with minimal guidance.
• Strong written and verbal communication skills.
• Proven problem-solving capabilities and a collaborative team mindset.

Preferred Qualifications

• Background in Quality Assurance (QA) within a regulated manufacturing environment.
• Direct experience with Batch Release or final product disposition processes.
• Familiarity with non-conformance documentation and root-cause analysis.
• Active involvement in process improvement initiatives.