MedTech Quality Engineer II - DHF/DMR & Regulatory Lead

Karl Storz Endoscopy; Charlton (MA); On-site; USD 74,000 - 96,000; Full time

Job summary

KARL STORZ is seeking a collaborative Quality Engineer to support product development projects across the medical device lifecycle at our Charlton, MA location. You will serve as a trusted quality partner ensuring regulatory compliance, patient safety, and product quality while aiding GPDP and DHF/DMR management.

You will work with Regulatory Affairs, Engineering, and cross-functional teams to establish design traceability, prepare for audits, and drive continuous improvement in quality systems.

Qualifications

• Bachelor's or Master's degree in Engineering, Quality, Life Sciences, or related field.
• 2–4 years of professional experience in quality management or regulated industry.
• Working knowledge of quality management systems, product lifecycle management, and regulatory requirements supporting medical device development.
• Experience managing technical documentation, including DHF, DMR, design controls, or similar development records.

Responsibilities

• Serve as the primary quality management contact for project teams, providing guidance on regulatory requirements, quality processes, and GPDP execution.
• Own and maintain compliant Design History Files (DHF) and Device Master Records (DMR), ensuring project documentation is complete, accurate, and audit-ready.
• Support phase gate reviews, design reviews, and product development activities to ensure compliance with applicable regulations, standards, and internal quality requirements.
• Partner with Regulatory Affairs, Engineering, and cross-functional stakeholders to establish design traceability from requirements through verification, validation, and product transfer.
• Coordinate internal and external audit preparation activities, represent development projects during audits, and ensure timely resolution of findings.
• Identify, assess, and mitigate quality and compliance risks while driving continuous improvement initiatives that enhance efficiency and product quality.

Skills

Communication skills

English proficiency

Organizational skills

MS Office

Education

Bachelor/Master in Engineering/Quality

Tools

SAP PLM

EasyDM

MS Project

Job description

KARL STORZ is seeking a collaborative Quality Engineer to support product development projects across the medical device lifecycle at our Charlton, MA location. You will serve as a trusted quality partner ensuring regulatory compliance, patient safety, and product quality while aiding GPDP and DHF/DMR management.

You will work with Regulatory Affairs, Engineering, and cross-functional teams to establish design traceability, prepare for audits, and drive continuous improvement in quality systems.