Quality Engineer II, Product Lifecycle Management

KARL STORZ North America; Charlton (MA); On-site; USD 74,000 - 96,000; Full time

Job summary

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.

Qualifications

• 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.

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

Documentation

Cross-functional collaboration

Regulatory knowledge

Education

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

Tools

SAP PLM

EasyDM

MS Project

Job description

About KARL STORZ

From the operating room to surgery centers—and everywhere in between—KARL STORZ North America is a global leader in medical technology and advanced visualization solutions. We design specialty innovations, smart instruments and devices, integrated ecosystems, and intelligent imaging—to build a more connected, software-enabled operating room.

About KARL STORZ

From the operating room to surgery centers—and everywhere in between—KARL STORZ North America is a global leader in medical technology and advanced visualization solutions. We design specialty innovations, smart instruments and devices, integrated ecosystems, and intelligent imaging—to build a more connected, software-enabled operating room.

As an independent, family-owned MedTech company, we ambitiously think in generations instead of quarters to improve patients’ lives around the world.

About The Role

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.

What You'll Do

• 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.

What You Bring

• 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 Have

• 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.

What Will Make You Successful

• You act as a quality enabler, building partnerships that help teams achieve compliance while maintaining project momentum.
• You are highly organized, detail-oriented, and capable of managing multiple priorities in a fast-paced environment.
• You take a proactive approach to identifying risks, solving problems, and driving continuous improvement.
• You communicate complex regulatory and quality concepts in a clear, practical, and actionable manner.
• You build strong relationships across functions and effectively influence stakeholders through collaboration rather than authority.
• You balance quality, compliance, customer needs, and business objectives to support successful product development outcomes.

Why KARL STORZ?

Join KARL STORZ and be part of a team creating medical innovations that truly make a difference. Beyond technology, you’ll be part of a culture that values talent as its greatest asset, empowering you to contribute to a mission that improves patient care worldwide.

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