Quality Engineer: Design, Validation & Manufacturing

Aspire Talent Solutions; Bay Shore (NY); On-site; USD 85,000 - 120,000; Full time

Job summary

Aspire Talent Solutions seeks a Quality Engineer to safeguard product quality across PDP from design through post-market. You will join cross-functional teams to implement QD&D activities, define quality requirements, and ensure compliance with ISO and FDA standards.

You will lead risk assessments, design verification, and root cause analysis, drive CAPA actions, support manufacturing, and monitor field performance to protect customers and improve processes.

Qualifications

• Bachelor’s degree in engineering, quality management, or related field.
• Proven experience in Quality Engineering in manufacturing or product development.
• Strong knowledge of QA methodologies, regulatory standards, and processes.

Responsibilities

• Quality Design & Development support during PDP; ensure quality requirements are defined and adhered to.
• Plan, execute, and monitor QA measures during new product development; perform risk assessments, design validation and verification.
• Provide ongoing quality support to sustaining manufacturing; lead root cause analysis and CAPA actions.
• Ensure quality during product distribution and post-market surveillance; coordinate with field teams.
• Maintain compliance with ISO, FDA, and other regulatory standards; prepare needed documentation for audits and submissions.
• Drive continuous improvement using data analysis to enhance product quality and efficiency.
• Collaborate with engineering, manufacturing, and supply chain to promote a culture of quality.

Skills

Quality assurance

Risk management

Root cause analysis

Communication

Problem solving

Education

Bachelor’s degree in engineering or quality management

Job description

Aspire Talent Solutions seeks a Quality Engineer to safeguard product quality across PDP from design through post-market. You will join cross-functional teams to implement QD&D activities, define quality requirements, and ensure compliance with ISO and FDA standards.

You will lead risk assessments, design verification, and root cause analysis, drive CAPA actions, support manufacturing, and monitor field performance to protect customers and improve processes.