What are the responsibilities and job description for the Senior Quality Engineer, Manufacturing position at MICRON PRODUCTS INC & SUBSIDIARIES?
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 is an on-site role, five days per week in our Fitchburg, MA office.
Candidates must have:
- Previous experience in medical device manufacturing quality
- A bachelor’s degree in engineering
This role is responsible for supporting 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 quality engineering.
What We Offer
- Competitive salary
- Comprehensive benefits package including health insurance, 401(k), and paid time off
- A positive, inclusive, and high-performing work environment
Please note: We are unable to provide sponsorship or relocation assistance at this time.
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.
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: At this time, we are not able to provide sponsorship for employment-based immigration visas (such as H-1B or other work authorization). Candidates must be legally authorized to work in the United States without the need for current or future sponsorship.
PM21
Salary : $100,000 - $125,000