Quality Engineer I: Drive Quality in High-Volume Manufacturing

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

Benefits offered by this job

Comprehensive benefits package

401(k) with company match

Parental leave

Paid time off (holidays)

Adoption benefits

Job summary

Integer Holdings Corporation is hiring an entry-level engineer focused on manufacturing quality and process improvement. The role emphasizes adherence to QMS, FDA regulations, and safety requirements, with guidance from senior engineers and managers.

You will support manufacturing quality, test method creation, non-conforming materials, and CAPA activities across site operations. The position offers base salary with a cash-based incentive, comprehensive benefits, and opportunities for continuous

Responsibilities

• Support regulatory inspections, audits, investigations, and inquiries regarding control and assessment of product design and manufacturing quality.
• Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and ensuring Device History Records are maintained.
• Review adequacy and correctness of changes to BOMs, Assembly Procedures, Drawings, Component Specifications, FMEAs, and Control Plans.
• Participate in continuous improvement projects and assist with product transfers.
• Develop and implement test methods, review processes for new/existing products, and coordinate validations and capability studies.
• Create and implement inspection protocols and procedures for Incoming, In-Process, and Final inspection.
• Lead root-cause analysis for non-conforming materials and participate in CAPA activities.
• Support internal quality audit activities and uphold the Quality Management System.
• Align strategies with site quality plans and sustain change management initiatives.

Job description

Integer Holdings Corporation is hiring an entry-level engineer focused on manufacturing quality and process improvement. The role emphasizes adherence to QMS, FDA regulations, and safety requirements, with guidance from senior engineers and managers.

You will support manufacturing quality, test method creation, non-conforming materials, and CAPA activities across site operations. The position offers base salary with a cash-based incentive, comprehensive benefits, and opportunities for continuous