Specialist - Quality Assurance

Description

The Quality Assurance Specialist supports the Quality Management System (QMS) by ensuring products, processes, and documentation comply with applicable regulatory requirements, internal procedures, and quality standards. This role assists in inspections, documentation control, complaint handling, and quality system maintenance to ensure product safety and effectiveness.

• Complaint Handling Support
• Assist with intake, documentation, and processing of customer complaints
• Support complaint investigations and ensure timely closure
• Help ensure complaints are evaluated for reportability

• Perform incoming, in-process, and final inspections of components and finished devices
• Verify product conformity to specifications, drawings, and procedures
• Record inspection results and ensure proper documentation in batch records (DHRs)

Assist with the compiling and reporting of quality and regulatory metrics.

• Ensure training records are maintained and up to date
• Support onboarding and training documentation for new employees

Other duties may be assigned by manager.

• Associate’s or Bachelor’s degree preferred.

• 0–3 years of experience in a regulated environment (medical device preferred).

Experience with ISO 13485 or FDA regulations is a plus.

• Strong attention to detail and documentation accuracy.
• Familiarity with quality tools (CAPA, NCR, audits).
• Ability to read and interpret technical documents and drawings.
• Good organizational and time management skills.
• Proficiency in Microsoft Office and/or eQMS systems.
• Strong communication and teamwork skills.

• Travel of approximately 20%
• Must be able to occasionally lift and move items weighing up to 35 pounds.