Quality Documentation Specialist – Medical Devices (1st Shift)

Regulatory Jobs

Northfield (NH)

On-site

USD 45,000 - 62,000

Full time

4 days ago
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Benefits offered by this job

Professional Development/On the Job 培训
Health and Wellness Benefits
Clean, Safe work Environment
Recognition and Rewards Program
Tuition Re-imbursement
Competitive Pay/Merit Increases
401k w/ Company Match
Employee Assistance Program (EAP)

Job summary

EPTAM Precision in Northfield, NH, is seeking a Quality Specialist for 1st shift to support our medical industry manufacturing. The role focuses on quality paperwork, FAI reviews, and ensuring conformance of MDHR/DHR before shipment, with involvement in audits and CTQ data analysis.

The ideal candidate has 3+ years in manufacturing, with strong documentation control and experience in regulatory paperwork for shipping.

Qualifications

  • High School diploma or GED required; trade school preferred.
  • 3+ years in a manufacturing environment; internships/PT acceptable.

Responsibilities

  • Support customer Quality paperwork and shipping requirements.
  • Perform FAI (First Article Inspection) reviews as per customer requirements.
  • Develop, review, and approve Quality document packages for shipping.
  • Organize and log MDHR/DHR for conformance before shipment.
  • Assist with customer/system audits related to quality paperwork.
  • Review CTQ data requirements when needed.
  • Review customer POs for adherence to requirements.
  • Ensure accuracy of paperwork, parts, and labeling prior to shipment.
  • Generate daily GDP error reports for quality control.

Skills

Quality Assurance
FAI Reviews
Quality Documentation
MDHR/DHR
Audits
FDA Inspections
Data Analysis
Documentation Control

Education

High School Diploma/GED
Trade School Preferred

Tools

Document Control Software
MS Office
Spreadsheets

Job description

EPTAM Precision in Northfield, NH, is seeking a Quality Specialist for 1st shift to support our medical industry manufacturing. The role focuses on quality paperwork, FAI reviews, and ensuring conformance of MDHR/DHR before shipment, with involvement in audits and CTQ data analysis.

The ideal candidate has 3+ years in manufacturing, with strong documentation control and experience in regulatory paperwork for shipping.

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