Quality Systems Engineer I — CAPA & Compliance

Haemonetics Software Solutions; Northern (KY); Hybrid; USD 68,000 - 116,000; Full time

Benefits offered by this job

401(k) with employer match

Employee stock purchase plan

Flexible time off

Vacation and sick time

Paid holidays

Parental leave

Disability insurance

Tuition reimbursement

Health and welfare benefits

Job summary

Haemonetics is seeking a Quality Engineer I to support manufacturing and quality operations in a high-volume environment. You will collaborate with Operations and Engineering to ensure products meet quality standards and regulatory requirements, including ISO 13485 and FDA 21 CFR Part 820.

Responsibilities include investigating defects, supporting CAPA, and driving process improvements while maintaining quality records and cross-functional partnerships.

Qualifications

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

Responsibilities

• Investigate CAPA, non-conformances, defects, and process failures to identify areas for improvement and lead or participate in resolution.
• Support QC Hold process and communicate hold information to stakeholders.
• Assist in manufacturing quality systems, product quality, and customer quality requirements.
• Support product improvement projects and supplier changes to ensure qualifications are met.
• Contribute to CAPA, cost reduction, process changes, and quality system excellence in projects.

Skills

Root cause analysis

Statistical process control

Quality systems

Problem solving

Education

Bachelor's Degree in Engineering or related field

Job description

Haemonetics is seeking a Quality Engineer I to support manufacturing and quality operations in a high-volume environment. You will collaborate with Operations and Engineering to ensure products meet quality standards and regulatory requirements, including ISO 13485 and FDA 21 CFR Part 820.

Responsibilities include investigating defects, supporting CAPA, and driving process improvements while maintaining quality records and cross-functional partnerships.