Quality Systems Engineering Intern

About Lexington Medical

Lexington Medical designs and manufactures AEON™ surgical stapling technology at our headquarters in Bedford, Massachusetts, just outside Boston. Our products are used in minimally invasive surgery, where precision, reliability, and quality matter every time. Because engineering, manufacturing, and quality work together under one roof, the people building and supporting our products are close to both the process and the decisions behind it.

About the Role

You will join our Quality team for the summer and own three projects that strengthen how we train our people and manage suppliers. Your main project is building out our training program. You will work with department heads to identify their highest priority Standard Operating Procedures (SOPs), write short knowledge check quizzes for each one, and roll them out in Arena so that anyone retraining to a procedure shows they understood it. On the production side, you will partner with manufacturing leads to review our pFMEAs, pinpoint the highest risk operations, and define how we evaluate training effectiveness for the operators who perform them. Alongside those projects, you will help bring our supplier quality records up to date by working directly with suppliers to refresh questionnaires and certificates and to gather REACH and RoHS compliance documentation that supports EU MDR compliance. You will not be siloed in one area. This role puts you in regular contact with Quality, Regulatory, Production, and department leaders across the company, and it is a strong introduction to quality systems, a side of engineering many students have not seen yet.

Responsibilities

• Write and maintain a project plan with milestones for your projects, and review progress weekly with your manager.
• Meet with department heads to identify the SOPs that matter most for their teams and prioritize them for training.
• Write 5 to 10 question knowledge check quizzes for priority SOPs and help roll them out in Arena as part of SOP retraining.
• Review product pFMEAs with production leads to identify the highest risk operations.
• Define and document methods for evaluating operator training effectiveness on those operations, then help carry out and record the assessments.
• Draft a work instruction that defines the training effectiveness process, so it continues after the summer.
• Contact suppliers to obtain updated quality questionnaires and certificates, following up until documentation is complete and on file.
• Request and track REACH and RoHS compliance documentation from suppliers to support EU REACH, RoHS, and MDR requirements.
• Escalate gaps or nonconforming findings to the Quality team.
• Present your projects and results to the team at the end of the summer.

Qualifications

• Currently pursuing a bachelor's degree in engineering (biomedical, mechanical, industrial, chemical, or a related discipline).
• Genuine interest in quality systems and how medical device companies build and maintain them.
• Strong attention to detail and comfort following written procedures.
• Clear written and verbal communication, since much of the role involves working with suppliers and colleagues across departments.
• Strong organization and follow-through, with the ability to keep several projects and requests moving at once.
• Self-motivated and comfortable taking ownership of work with guidance rather than step‑by‑step direction.
• A plus: basic familiarity with ISO 13485, 21 CFR 820 / QMSR, or EU MDR.
• A plus: prior internship or co‑op experience, especially in medical devices.

Pay

Hourly Rate $24—$32 USD