Quality Engineer - FDA Regulated Products

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.