Quality Engineer II: MedTech PLM & Compliance

KARL STORZ SE & Co. KG; Charlton (MA); On-site; USD 74,000 - 96,000; Full time

Benefits offered by this job

Medical/Dental/Vision

Vacation & holidays

401(k) match

Tuition reimbursement

Wellness program

Job summary

KARL STORZ North America is seeking a Quality Engineer II to support product lifecycle management for medical devices. Based in Charlton, MA, you will partner with regulatory affairs, engineering, and quality teams to ensure DHF/DMR, design controls, and GPDP alignment across projects.

You will drive audit readiness, risk assessment, and process improvements to maintain compliance and patient safety while delivering quality outcomes in a fast-paced environment.

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 product development.
• Working knowledge of quality management systems and medical device regulations.
• Experience managing DHF/DMR and design controls.

Responsibilities

• Serve as primary quality contact for project teams and GPDP execution.
• Own DHF and DMR, ensuring audit-ready documentation and compliance.
• Support phase gates, design reviews, and regulatory alignment.
• Coordinate design traceability from requirements through transfer.
• Prepare for internal and external audits and address findings.
• Identify and mitigate quality risks and drive continuous improvement.

Skills

Quality management

Regulatory compliance

Documentation control

Cross-functional collaboration

Education

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

Tools

SAP PLM

EasyDM

MS Project

Job description

KARL STORZ North America is seeking a Quality Engineer II to support product lifecycle management for medical devices. Based in Charlton, MA, you will partner with regulatory affairs, engineering, and quality teams to ensure DHF/DMR, design controls, and GPDP alignment across projects.

You will drive audit readiness, risk assessment, and process improvements to maintain compliance and patient safety while delivering quality outcomes in a fast-paced environment.