Quality Engineer II — Medical Device PLM & Compliance

KARL STORZ North America; Charlton (MA); Vor Ort; USD 74.000 - 96.000; Vollzeit

Zusammenfassung

KARL STORZ North America is seeking a collaborative Quality Engineer to support medical device development. You will partner with project teams to ensure regulatory compliance, patient safety, and product quality throughout the lifecycle.

Responsibilities include managing DHF/DMR, supporting design reviews, and driving continuous improvement. Ideal candidates hold a degree in engineering or life sciences and have 2–4 years in a regulated environment with strong communication skills.

Qualifikationen

• Bachelor's or Master's degree in Engineering, Quality, Life Sciences, or a related discipline.
• 2–4 years of 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.

Aufgaben

• 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.

Kenntnisse

Quality management

Documentation

Cross-functional collaboration

Regulatory knowledge

Ausbildung

Bachelor's or Master's degree in Engineering, Quality, Life Sciences, or a related discipline

Tools

SAP PLM

EasyDM

MS Project

Jobbeschreibung

KARL STORZ North America is seeking a collaborative Quality Engineer to support medical device development. You will partner with project teams to ensure regulatory compliance, patient safety, and product quality throughout the lifecycle.

Responsibilities include managing DHF/DMR, supporting design reviews, and driving continuous improvement. Ideal candidates hold a degree in engineering or life sciences and have 2–4 years in a regulated environment with strong communication skills.