Micron Solutions ยท 3 weeks ago
Senior Quality Engineer, Manufacturing
fitchburg, MA 01420
Full-time
Onsite
Senior Level
$100K/yr - $125K/yr
7+ years expMicron Solutions is a multifaceted contract manufacturing organization specializing in thermoplastic injection molding, precision machining and finishing, and silver-plated medical sensors for disposable electrodes. 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.
Facilities Services
No H1B
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
Qualification
Required
Previous experience in medical device manufacturing quality
A bachelor's degree in engineering
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
Leadership and team collaboration
Strong attention to detail and compliance
Continuous improvement mindset
Ability to manage multiple priorities independently in a regulated environment
Preferred
Bachelor's degree in Engineering (Mechanical or Industrial preferred)
ASQ Certified Quality Engineer (CQE)
Six Sigma Green/Black Belt
Benefits
Comprehensive benefits package including health insurance, 401(k), and paid time off
Company
Micron Solutions
Micron Solutions is a micro machine shop specializing in servicing your requirements for micro machined parts.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase