Quality Systems Engineer I — Elevate Medical Device QA

Haemonetics Corp; Pennsylvania; On-site; USD 68,000 - 116,000; Full time

Job summary

Haemonetics Corp. seeks a Quality Engineer I to bolster manufacturing and quality operations in a high-volume environment with automated equipment and vision inspection systems.

You will help ensure compliance with ISO 13485 and FDA 21 CFR Part 820 while supporting cross-functional initiatives. The role collaborates with Operations, Engineering, and R&D to sustain product quality, lead CAPA activities, and implement process improvements.

Qualifications

• Bachelor's Degree in Engineering or related field.
• Related experience in a regulated manufacturing environment.
• Excellent organization skills.
• Experience performing root cause analysis and statistical process control.
• Previous experience in medical device, preferred.

Responsibilities

• Work with relevant departments and stakeholders to investigate CAPA, non-conformances, defects, and process failures to identify areas in need of process improvement.
• Support QC Hold process to understand product issues, providing required QA input, taking necessary actions, and communicating hold information to relevant stakeholder groups.
• Assists in manufacturing quality systems, product quality and customer quality requirements.
• Supports product improvement projects (validation IQ, OQ, PQ activities) and supplier changes to ensure qualification are met.
• Completes or may lead teams/projects related to CAPA, cost reduction, process changes, manufacturing transfers and quality system excellence.
• Conducts risk analysis as needed.
• Develops, reviews and challenges existing quality driven test systems and procedures to assure products meet intended use.
• Maintains records to ensure compliance to GMP/Regulatory requirements.
• Monitors internal and external quality levels to trigger and drive improvements to maintain product compliance.
• Provide individual contribution in problem solving efforts on selected projects to improve quality.
• Partner with Manufacturing Engineering, Operations, Supplier Quality, Quality Control, and R&D teams as needed providing quality guidance.

Skills

Root cause analysis

Statistical process control

Education

Bachelor's Degree in Engineering

Job description

Haemonetics Corp. seeks a Quality Engineer I to bolster manufacturing and quality operations in a high-volume environment with automated equipment and vision inspection systems.

You will help ensure compliance with ISO 13485 and FDA 21 CFR Part 820 while supporting cross-functional initiatives. The role collaborates with Operations, Engineering, and R&D to sustain product quality, lead CAPA activities, and implement process improvements.