Sr. Quality Engineer - Medical Device Manufacturing

Job Description

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

Compensation details: 90000-110000