Quality Engineer II — Medical Device PLM & Compliance

KARL STORZ; Folkston (GA); On-site; USD 74,000 - 96,000; Full time

Job summary

KARL STORZ North America is seeking a collaborative Quality Engineer to support product development teams through the medical device lifecycle. You will ensure DHF/DMR readiness, audit preparation, and GPDP compliance while focusing on patient safety and product quality.

Based in Charlton, MA, the role may require occasional travel up to 10% and involves partnering with Regulatory Affairs, Engineering, and Quality to drive continuous improvement and efficient documentation.

Qualifications

• Bachelor's or Master's degree in Engineering, Quality, Life Sciences, or a related discipline.
• Minimum 2–4 years of professional experience in quality management, product development, regulatory affairs, or a related role within a 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.
• Strong written and verbal English communication skills with the ability to collaborate across multiple functions and levels of the organization.
• Proficiency with Microsoft Office applications; familiarity with SAP PLM, EasyDM, and MS Project is beneficial.

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

Quality management

English communication

MS Office proficiency

Regulatory awareness

Education

Bachelor's or Master's degree in Engineering/Quality/Life Sciences

Tools

SAP PLM

EasyDM

MS Project

Microsoft Office

Job description

KARL STORZ North America is seeking a collaborative Quality Engineer to support product development teams through the medical device lifecycle. You will ensure DHF/DMR readiness, audit preparation, and GPDP compliance while focusing on patient safety and product quality.

Based in Charlton, MA, the role may require occasional travel up to 10% and involves partnering with Regulatory Affairs, Engineering, and Quality to drive continuous improvement and efficient documentation.