Quality Engineer - FDA Regulated Products

Quality Engineer, FDA Regulated Product Development

Location: Bay Shore, NY (On-site)
Job Type: Full-time, Direct Hire
Pay: $90,000 to $110,000 per year

Build quality into products from the first design phase through manufacturing and the field, with real ownership across the full product lifecycle.

Must-Haves

• Bachelor's degree in Engineering, Quality Management, or a related field
• Proven experience as a Quality Engineer in manufacturing or product development
• Knowledge of ISO and FDA regulatory requirements
• Strong skills in risk management, root cause analysis, and CAPA
• Solid understanding of quality assurance methods and product development processes
• Excellent communication and problem-solving skills

What You'll Do

• Support new product development by defining and enforcing quality requirements from design onward
• Lead risk assessments, design verification, and design validation
• Provide sustaining manufacturing quality support and resolve production quality issues
• Lead root cause analysis and drive corrective and preventive actions
• Support post-market surveillance and partner with field teams on product performance
• Maintain documentation for regulatory submissions and audits
• Use data and metrics to drive continuous improvement in quality systems
• Partner with engineering, manufacturing, and supply chain to build a culture of quality

Nice-to-Haves

• ASQ Certified Quality Engineer (CQE)
• Six Sigma certification
• Medical device or FDA-regulated manufacturing experience

Compensation and Benefits

• $90,000 to $110,000 per year
• Direct hire opportunity

About the Company
Our client is an established Long Island manufacturer developing and producing products in a regulated industry.

To apply, submit your resume for consideration.