Incoming Materials Quality Auditor (ISO 13485)
Role Snapshot
Contract: Through 5/21/27
Location: Shrewsbury, MA
Pay: $30–$37/hr
Schedule: 7:00 a.m. – 3:30 p.m., Monday–Friday
As the Incoming Materials Quality Auditor, you’ll be embedded in our Quality Management System and report directly to the Quality Inspector Lead, QA Manager, or Director . Your mission: inspect, audit, and document the quality of supplier materials and in-house processes using visual techniques and precision metrology to ensure they meet both organizational and customer standards.
A Day in the Life
At 7:00 a.m., you begin by sampling new supplier lots using established sampling plans . You review engineering drawings, specifications, purchase orders, statements of work, and standards to determine part acceptance. With calipers, micrometers, a Micro-hite, and a comparator , you verify features on machined components to drawing requirements. Accepted items receive part number labels per the inventory part labeling specification . You stay current with and follow all relevant SDS (Safety Data Sheets) for any chemical handling involved in materials review.
Throughout the day, you communicate verbally and in writing with management regarding all Non-Conforming Material (NCM) , lead NCM activities , and support Root Cause Investigations to closure . You contribute to Corrective Actions, Deviations, and Complaints , perform and document First Article Inspections (FAI) , and assist during Internal, Supplier, and Customer Audits . You complete every aspect of non-conforming material reports —from review and investigations through approvals—while keeping meticulously organized records in Microsoft Outlook, Excel, and Word . You also identify and communicate continuous improvement opportunities for both internal teams and external customers. Safety and personnel policy compliance guide your work from start to finish.
Qualifications
- Bachelor’s degree in a science discipline, or 5+ years of relevant experience.
- 3–5 years in an ISO 9001 or ISO 13485 certified Quality Management System (or equivalent).
- Familiar with inspection practices/standards in medical devices, bioprocessing equipment, military, or aerospace .
- Demonstrated proficiency with inspection tools and precision measurement (calipers, micrometers, Micro-hite , comparator).
- Experienced inspecting machined parts to drawing requirements using precision measuring tools.
- Working knowledge of sampling plans and understanding of Good Documentation Practices (preferred).
- Skilled with Microsoft Office (Outlook, Excel, Word); excellent organization and timely documentation.
- Clear cross-functional communicator; shares daily progress; contributes effectively to project teams.
- Exceptional attention to detail.
Physical Requirements
- Regularly required to bend, reach, stand, walk, and sit daily.
- Eyesight must be correctable to the level required to detect cosmetic and workmanship type defects.
You’re Proficient In
- ISO 13485
- First Article Inspection (FAI)
Machines & Technologies You’ll Use
- Calipers and Micrometers
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