Quality Systems Engineer I — GMP/Regulated QC

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

Benefits offered by this job

401(k) match

Employee stock purchase plan

Flexible time off

Paid vacation

Paid sick time

Holidays

Disability insurance

Tuition reimbursement

Health benefits

Job summary

The Quality Engineer I at Haemonetics supports manufacturing and quality operations by ensuring products and processes meet defined standards. This role collaborates with Operations and Engineering in a high-volume setting using automated equipment and vision inspection systems.

You will help maintain ISO 13485 and FDA 21 CFR Part 820 compliance and work cross-functionally to drive quality improvements across production and supplier quality, CAPA, and process validation activities.

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

• Investigate CAPA, non-conformances, defects, and process failures and lead improvements.
• Support QC Hold process and communicate hold information to stakeholders.
• Assist in manufacturing quality systems and supplier quality requirements.
• Support product improvement projects and supplier changes to ensure qualifications.
• Lead or participate in CAPA, cost reduction, and quality system initiatives.
• Conduct risk analysis as needed.
• Develop and improve quality-driven test systems and procedures.
• Maintain records to ensure GMP/Regulatory compliance.
• Monitor quality levels and drive improvements across production.

Skills

Root cause analysis

Statistical process control

Regulated manufacturing

Education

Bachelor's Degree in Engineering or related field

Job description

The Quality Engineer I at Haemonetics supports manufacturing and quality operations by ensuring products and processes meet defined standards. This role collaborates with Operations and Engineering in a high-volume setting using automated equipment and vision inspection systems.

You will help maintain ISO 13485 and FDA 21 CFR Part 820 compliance and work cross-functionally to drive quality improvements across production and supplier quality, CAPA, and process validation activities.