Senior Quality Engineer

Senior Quality Engineer

MICRON PRODUCTS - 3.2

Fitchburg, MA Job Details Full-time $90,000 - $110,000 a year 5 hours ago Benefits Health insurance 401(k) Paid time off Qualifications Statistics Customer communication Defect resolution root cause analysis ISO standards Quality control statistical data analysis ERP systems Statistical Process Control Six Sigma methodology implementation GD&T Microsoft Office Statistical analysis Bachelor's degree in engineering Production validation processes Quality risk management Medical device manufacturing facility experience Data-driven problem-solving Biomedical regulatory compliance Operational excellence initiatives Quality improvement programs in engineering Technical Proficiency FDA regulations Customer complaint resolution Failure analysis Full Job Description Senior Quality Engineer fitchburg, MA 01420 Description

JOB PURPOSE

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.

What We Offer:

Competitive salary Comprehensive benefits package, including health insurance, 401(k), and paid time off.

KEY ACCOUNTABILITIES

Regulatory & Quality Compliance 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. Process & Product Quality 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. Risk Management & Documentation 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. Continuous Improvement 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. Customer & Supplier Interface 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. Qualifications

JOB QUALIFICATIONS

Education:

Bachelor's degree in Engineering (Mechanical or Industrial preferred)

Experience:

Minimum 7+ years in quality engineering within medical device manufacturing or assembly Strong knowledge of

ISO 13485, FDA

QMSR, and risk management principles

Skills:

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. Preferred Certifications ASQ Certified Quality Engineer (CQE) Six Sigma Green/Black Belt Core Competencies Leadership and team collaboration Strong attention to detail and compliance Continuous improvement mindset Ability to manage multiple priorities independently in a regulated environment PM21 Compensation details: 90000-110000 PIaefdd3fba7ed-25404-40606237