Quality Engineer I - Entry-Level, Process Improvement

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

Job summary

Integer Holdings is seeking an entry-level engineer to support quality and manufacturing activities at our Hudson, MA site. You will work under guidance from experienced engineers to ensure customer expectations are met, with a strong emphasis on quality processes and regulatory compliance.

You will assist with CAPA; participate in plant quality initiatives; and contribute to continuous improvement and product transfers while following established QMS and FDA guidelines.

Qualifications

• Assists with regulatory inspections, audits and inquiries.
• Supports compliance with Quality Management Systems (QMS).
• Applies data analysis to identify root causes of failures.

Responsibilities

• Support regulatory inspections, audits, investigations and inquiries regarding design and manufacturing quality.
• Monitor manufacturing to ensure compliance with DMR and maintain Device History Records.
• Review changes to BOMs, assembly procedures, drawings, specs and FMEAs.

Skills

Quality systems

FDA regulations

CAPA management

Audit support

BOM review

Process improvement

Job description

Integer Holdings is seeking an entry-level engineer to support quality and manufacturing activities at our Hudson, MA site. You will work under guidance from experienced engineers to ensure customer expectations are met, with a strong emphasis on quality processes and regulatory compliance.

You will assist with CAPA; participate in plant quality initiatives; and contribute to continuous improvement and product transfers while following established QMS and FDA guidelines.