Quality Engineer - Medical Device

Quality Engineer
Bay Shore, NY

This role supports quality assurance and quality engineering across the full product lifecycle, from early design through sustaining manufacturing and post market support. The Quality Engineer works cross functionally with design, manufacturing, and supply chain teams to make sure products meet regulatory requirements and hold up to customer expectations in the field.

Schedule: To be confirmed with employer.

Compensation: $90,000 to $110,000 per year.

What You'll Do
The Quality Engineer supports Quality Design and Development (QD&D) activities during the Product Development Process, working with cross functional teams to define, implement, and maintain quality requirements through the design and development stages. This includes planning, executing, and monitoring quality assurance measures for new product development, along with risk assessments and design validation and verification work to confirm products meet design intent and regulatory standards.

On the manufacturing side, this role provides ongoing quality support to sustaining production teams, identifying and investigating quality issues and leading root cause analysis and corrective action to keep production consistent. The role also covers quality assurance during product distribution and supports post market surveillance, monitoring product performance in the field and working with field teams to resolve quality concerns as they come up.

Compliance is a core part of the job: maintaining adherence to applicable regulatory standards (ISO, FDA, and other relevant industry regulations) and preparing documentation for regulatory submissions and audits. The Quality Engineer also drives continuous improvement in quality processes and systems, using data analysis to find improvement opportunities and implement solutions.

Required Qualifications

• Bachelor's degree in engineering, quality management, or a related field
• Experience as a Quality Engineer in a manufacturing or product development environment
• Strong knowledge of quality assurance methodologies, product development processes, and regulatory requirements
• Proficiency in risk management, root cause analysis, and corrective/preventive action (CAPA) processes
• Strong communication and problem solving skills

Preferred Qualifications

• Certification in a quality management system (Six Sigma or ASQ Certified Quality Engineer)
• Experience with FDA regulated or ISO certified manufacturing environments
• Experience supporting regulatory audits or submissions

Compensation and Benefits

• $90,000 to $110,000 per year
• Medical, dental, and vision insurance
• 401k 
• Paid time off 

To apply, submit your resume for consideration.