Senior Quality Engineer

MICRON PRODUCTS INC & SUBSIDIARIES•Fitchburg, MA

32d•$90,000 - $110,000•Onsite

About The Position

The Senior Quality Engineer ensures compliance with FDA regulations, ISO 13485 standards, and customer requirements for the manufacturing and assembly of molded and machined components, including medical device components and assemblies. This role is responsible for maintaining a robust Quality Management System (QMS), driving continuous improvement, and supporting product quality throughout the lifecycle. The engineer serves as a technical expert in risk management, process controls, and regulatory compliance.

Requirements

Bachelor’s degree in Engineering (Mechanical or Industrial preferred)
Minimum 7+ years in quality engineering within medical device manufacturing or assembly
Strong knowledge of ISO 13485, FDA QMSR, and risk management principles
Proficiency in lean principles and continuous improvement methodologies.
Strong computer skills (MS Office, ERP systems, electronic QMS systems).
Expertise in quality tools: Root Cause Analysis, SPC, FMEA, MSA, GD&T.
Experience with metrology, process validation and statistical analysis
Excellent problem-solving, analytical, organizational and communication skills.

Nice To Haves

ASQ Certified Quality Engineer (CQE)
Six Sigma Green/Black Belt
Leadership and team collaboration
Strong attention to detail and compliance
Continuous improvement mindset
Ability to manage multiple priorities independently in a regulated environment

Responsibilities

Maintain and enhance QMS in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
Lead internal, customer, and regulatory audit activities, including preparation and response.
Ensure adherence to Good Manufacturing Practices (GMP) and risk-based quality approaches.
Develop and implement quality plans, inspection methods, and control plans for medical device components.
Lead root cause analysis and corrective/preventative actions (CAPA) for nonconformances and complaints.
Collaborate with engineering and production teams on new product launch introductions, including process validation (IQ/OQ/PQ) and equipment qualification.
Conduct risk assessments per ISO 14971 and maintain risk files.
Prepare and maintain quality documentation, including Device History Records (DHR), validation reports, and audit findings.
Ensure proper document control and traceability for all components and assemblies.
Drive initiatives using Lean, Six Sigma, and statistical methods to reduce defects and improve yield.
Analyze quality metrics (scrap, rework, complaints) and implement corrective actions.
Serve as primary quality contact for medical device OEM customers, addressing concerns and ensuring satisfaction.
Support supplier quality activities, including qualification, audits, and performance monitoring.