Quality Records Specialist (ISO 13485)

McCollister's; Village of Menands (NY); On-site; USD 28,000 - 32,000; Full time

Job summary

McCollister's in Menands, NY is seeking a Quality Clerk to support QA and QMS activities in a medical device manufacturing environment. You will maintain quality records, assist with document control, and help with inspections and audits to ensure documentation is accurate and compliant with ISO 13485 and regulatory requirements.

Reporting to the General Manager, this regular full-time role requires strong attention to detail, excellent organization, and the ability to manage multiple tasks in a

Qualifications

• High school diploma or equivalent required; associate degree preferred.
• Experience in quality, manufacturing, or regulated industries preferred.
• Familiarity with ISO 13485 and QMS is preferred.
• Strong attention to detail and accuracy.
• Ability to maintain confidential information.

Responsibilities

• Maintain and organize quality records and inspection reports.
• Perform accurate data entry and update quality information.
• Assist document control activities and filing of controlled documents.
• Review records for completeness and proper approvals.
• Support CAPA, nonconformances, deviations, and audits.
• Assist with audit documentation and records and respond to requests.

Skills

Quality records

Data entry

Document control

Audit support

Attention to detail

Communication

Education

High school diploma

Associate degree or technical education preferred

Tools

Microsoft Word

Microsoft Excel

QMS software

Job description

McCollister's in Menands, NY is seeking a Quality Clerk to support QA and QMS activities in a medical device manufacturing environment. You will maintain quality records, assist with document control, and help with inspections and audits to ensure documentation is accurate and compliant with ISO 13485 and regulatory requirements.

Reporting to the General Manager, this regular full-time role requires strong attention to detail, excellent organization, and the ability to manage multiple tasks in a