Senior Quality Engineer, Contract Manufacturing

Job Description

Job Description

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: 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



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