Quality Engineer II, Product Lifecycle Management

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. **Eligible Employee Benefits** - Medical / Dental / Vision including a state-of-the-art wellness program and access to pet insurance, too! - 3 weeks vacation accrual for full time roles,* paid holidays plus paid sick time too - Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child. - 401(k) retirement savings plan providing a match of 66.67% (4%) of the employee's first 6% contribution (up to IRS limits) - Section 125 Flexible Spending Accounts - HSA Savings Accounts with company contribution - Life, STD & LTD Insurance - We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement - Fitness reimbursement of up to $200 annually - And much more! * Field sales, internships, and roles that are regularly scheduled to work less than 30 hours per week are not eligible for vacation, except where required by law. Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program. KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employees must comply will all applicable KARL STORZ policies and procedures. **Credentialing requirements at KARL STORZ** KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements. **Pay Transparency** The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member's base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role. **Get in Contact** 5810