Senior Quality Engineer

Key Accountabilities :

• 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.

JOB QUALIFICATIONS Education : Bachelors degree in Engineering (Mechanical or Industrial preferred) Experience :

Skills :

Preferred Certifications

Core Competencies

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

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