Specialist - Quality Assurance
About The Position
The Quality Assurance Specialist supports the Quality Management System (QMS) by helping ensure products, processes, and documentation comply with applicable regulatory requirements, internal procedures, and quality standards. The role assists with inspections, documentation control, complaint handling, and quality system maintenance to support product safety and effectiveness. The Specialist supports customer complaint intake, documentation, processing, investigation, and timely closure, and helps ensure complaints are evaluated for reportability. The role performs incoming, in-process, and final inspections of components and finished devices; verifies product conformity to specifications, drawings, and procedures; records inspection results; and ensures proper documentation in batch records (DHRs). The Specialist also helps compile and report quality and regulatory metrics, maintains training records, and supports onboarding and training documentation for new employees. Other duties may be assigned by the manager.
Requirements
- 0–3 years of experience in a regulated environment; medical device experience is preferred.
- Strong attention to detail and documentation accuracy.
- Familiarity with quality tools such as CAPA, NCR, and 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%.
- Ability to occasionally lift and move items weighing up to 35 pounds.
Nice To Haves
- Associate’s or Bachelor’s degree preferred.
- Experience with ISO 13485 or FDA regulations is a plus.
- Medical device experience is preferred.
Responsibilities
- 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 compiling and reporting quality and regulatory metrics.
- Ensure training records are maintained and up to date.
- Support onboarding and training documentation for new employees.
- Perform other duties as assigned by the manager.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
