Quality Engineer

Summary:
We are seeking a Quality Engineer with experience in the medical device industry to support quality assurance, regulatory compliance, and continuous improvement initiatives. The ideal candidate will have a strong background in FDA regulations, ISO 13485, risk management (ISO 14971), and product lifecycle management, including design control and CAPA systems.

Roles & Responsibilities:

• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulatory standards.
• Support design control activities including design verification/validation, risk analysis (FMEA, FTA), and product release.
• Develop and maintain quality documentation, including SOPs, work instructions, inspection plans, and validation protocols.
• Perform root cause investigations and drive Corrective and Preventive Actions (CAPA) to resolution.
• Conduct or support internal audits, supplier audits, and regulatory inspections.
• Monitor and improve product quality metrics (yield, complaints, non-conformances, etc.).
• Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory, Supply Chain) to ensure quality is built into processes and products.
• Lead or assist in supplier quality management activities, including qualifications, audits, and performance monitoring.
• Participate in risk management processes and ensure appropriate risk controls are implemented.
• Support change control processes for product or process changes.
• Contribute to continuous improvement initiatives using tools such as Six Sigma, Lean, and 8D.

Education & Experience :

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 2-5+ years of quality engineering experience in the medical device or regulated industry.
• Strong knowledge of FDA QSR (21 CFR Part 820) and ISO 13485.
• Experience with risk management (ISO 14971) and design control practices.
• Hands-on experience with CAPA, Company, validations (IQ/OQ/PQ), and audits.
• Proficient in quality tools such as FMEA, 8D, Root Cause Analysis, etc.
• Excellent analytical, documentation, and communication skills.