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 QUALIFICATIONSEducation: Bachelors 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

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