Quality Systems Specialist
Listed on 2026-07-01
-
Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager, Production QC/QA, Regulatory Compliance Specialist
Overview
Ready to make your mark in quality excellence? We're seeking a passionate, detail-oriented Quality Specialis
t to drive impactful documentation and administrative support for our established ISO 13485 Quality Management System at our dynamic Hopkinton facility
.
This exciting on-site opportunity is perfect for an independent, self‑motivated professional who thrives on supporting multiple cross‑functional teams while upholding the highest standards of quality excellence. You'll be at the heart of our quality operations, making a real difference in our mission to deliver exceptional products and services.
Core Duties and Responsibilities- Manage QMS training for the site
- Coordinate and process Change Orders in the Document Control system
- Coordinate the tracking and follow‑up of Corrective/Preventive Actions (CAPA) for the site
- Coordinate the tracking and follow‑up of Internal Audits for the site
- Assist with the compiling and reporting of Quality metrics
- Assist the complaint coordinator with administration and tracking of customer complaints
- Complete data entry and archiving tasks in various electronic systems, including SAP
- Provide documentation support as needed across the organization
- Interface with colleagues across the global organization in the conduct of utilizing corporate systems for the local site
- Perform other quality‑related assignments and tasks as needs arise
- Batchlor's Degree AND 2 years of Quality Assurance experience working within a quality management system (QMS) OR
- Associate's degree AND 3 years of Quality Assurance experience within a quality management system (QMS)
- Strong MS Word and Excel skills required
- Computer proficiency with background in SAP business information systems a plus
- Working knowledge of ISO 9001 and/or 13485 Standards
- Data Analysis skills
Base salary range: $71,000.00 - $94,500.00 per year. This reflects the minimum and maximum target for a new hire in this position. Salary offered will consider internal equity, work location, and relevant education or training.
What do we offer- Medical, Dental, and Vision Insurance Options
- Life and Disability Insurance
- Paid Time‑Off
- Parental Benefits
- Compassionate Care Leave
- 401k with Company Match
- Employee Stock Purchase Plan
For benefit‑eligible roles only. Part‑time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.
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