Senior Quality Engineer

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.

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