Quality Systems Engineer I (Medical Devices)

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

Benefits offered by this job

401(k) with employer match

Employee stock purchase plan

Flexible time off

Job summary

Haemonetics seeks a Quality Engineer I to support manufacturing and quality operations in a high-volume setting. You will ensure products and processes meet defined quality standards, align with ISO 13485 and FDA 21 CFR Part 820, and collaborate across Operations and Engineering to drive quality initiatives.

You will participate in CAPA, QC Hold processes, and product improvement projects, ensuring qualification and regulatory compliance while maintaining thorough documentation for GMP standards.

Qualifications

• Bachelor's degree in engineering or related field required.
• Experience in a regulated manufacturing environment preferred.
• Strong analytical and organizational skills, with SPC experience.

Responsibilities

• Investigate CAPA, non-conformances, defects, and process failures to drive improvements.
• Support QC Hold processes and communicate hold information to stakeholders.
• Assist in manufacturing quality systems and product quality requirements.
• Support product improvement projects and supplier changes to ensure qualifications.
• Lead or participate in CAPA, cost reduction, process changes, and quality system initiatives.
• Perform risk analyses as needed and ensure GMP/regulatory compliance.
• Develop and challenge quality-driven test systems and procedures.
• Maintain records to comply with GMP and regulatory standards.
• Monitor internal/external quality levels and drive improvements.

Skills

Root cause analysis

Statistical process control

Organizational skills

Education

Bachelor's Degree in Engineering or related field

Job description

Haemonetics seeks a Quality Engineer I to support manufacturing and quality operations in a high-volume setting. You will ensure products and processes meet defined quality standards, align with ISO 13485 and FDA 21 CFR Part 820, and collaborate across Operations and Engineering to drive quality initiatives.

You will participate in CAPA, QC Hold processes, and product improvement projects, ensuring qualification and regulatory compliance while maintaining thorough documentation for GMP standards.