Quality Engineer II, Product Lifecycle Management

KARL STORZ•Charlton, MA

22h•$73,600 - $95,600•Onsite

About The Position

We are seeking a collaborative and solutions-oriented Quality Engineer to support product development teams throughout the medical device lifecycle. In this role, you will serve as a trusted quality partner, ensuring development projects meet global regulatory requirements while maintaining a strong focus on patient safety, product quality, and operational efficiency. You will play a key role in Design History File (DHF) and Device Master Record (DMR) management, audit readiness, quality system compliance, and cross-functional support of our Global Product Development Process (GPDP). This role offers the opportunity to work closely with project managers, engineering, regulatory affairs, and quality teams while helping drive continuous improvement initiatives that strengthen compliance and accelerate innovation across KARL STORZ. This role may require occasional travel up to 10%.The base salary for this position is $73,600 - $95,600 and based in our Charlton, MA location.

Requirements

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.

Nice To Haves

Experience in the medical device industry or another highly regulated environment.
Experience supporting internal, external, or regulatory audits.
Knowledge of MDR, FDA regulations, ISO 14971, IEC 60601, IEC 62304, or related medical device standards.

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.