Sr. Quality Engineer - Medical Device Manufacturing

Sr. Quality Engineer - Medical Device Manufacturingfitchburg, MA 01420

Description Micron Solutions is a multifaceted contract manufacturing organization specializing in thermoplastic injection molding, precision machining and finishing, and silver-plated medical sensors for disposable electrodes. We collaborate with clients of all sizes to provide manufacturing solutions and assembly services that support their goals from concept to commercialization. Our 120,000 square foot Fitchburg, MA facility is equipped to manage projects across the full product lifecycle.

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

Please note:

This position is not eligible for visa sponsorship. Applicants must be authorized to work in the United States without current or future sponsorship requirements.

PM21

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