Entry-Level Quality Engineer: CAPA & Process Improvement

Integer Holdings Corporation; Hudson (MA); On-site; USD 64,000 - 93,000; Full time

Benefits offered by this job

Medical, dental, vision

disability insurance

Life insurance

Adoption benefits

401(k) with company match

Paid holidays

Paid time off

Job summary

Integer Holdings Corporation is seeking an entry-level engineer to support quality and manufacturing operations. You will work under guidance to ensure compliance with QMS, FDA regulations, and safety requirements while assisting in CAPA, MRB, and audit activities.

You will monitor manufacturing processes, review changes to BOMs and procedures, and participate in continuous improvement projects as part of a high-volume production environment.

Qualifications

• Entry-level engineer with guidance from more experienced engineers and managers.
• Must adhere to FDA regulations, QMS and safety requirements.
• Experience with CAPA, MRB, audits, and change management is a plus.

Responsibilities

• Support regulatory inspections, audits, investigations, and inquiries related to device design and manufacturing quality.
• Monitor manufacturing for compliance and maintain Device History Records.
• Review changes to BOM, assembly procedures, drawings, and FMEAs.
• Participate in continuous improvement projects and product transfers.
• Collaborate with others to exchange information and ensure understanding in development.

Skills

Quality management

Regulatory compliance

Cross-functional collaboration

Root cause analysis

Process improvement

Education

Bachelor's degree in Engineering

Tools

QMS software

BOM review tools

Job description

Integer Holdings Corporation is seeking an entry-level engineer to support quality and manufacturing operations. You will work under guidance to ensure compliance with QMS, FDA regulations, and safety requirements while assisting in CAPA, MRB, and audit activities.

You will monitor manufacturing processes, review changes to BOMs and procedures, and participate in continuous improvement projects as part of a high-volume production environment.