Quality Systems Intern Build Training & Supplier Compliance

Lexington Medical, Inc.; Bedford, Northern (MA, KY); Hybrid; USD 25,000 - 39,000; Full time

Job summary

Lexington Medical, Inc. in Bedford, MA seeks a Quality Systems Engineering Intern to drive three real projects, from training program development to supplier documentation updates.

You’ll work closely with Quality, Regulatory, Production, and department leaders to implement SOPs and assess training effectiveness. The role offers hands-on experience in medical-device quality systems, pFMEAs, and EU MDR documentation, preparing you for a career in quality engineering within a fast-paced

Qualifications

• Pursuing a bachelor’s degree in engineering or related field.
• Genuine interest in quality systems for medical devices.
• Strong attention to detail and comfort following procedures.
• Clear written and verbal communication across departments.
• Strong organization and ability to manage multiple projects.
• Self-motivated with guidance.
• Familiarity with ISO 13485, 21 CFR 820 / QMSR, or EU MDR is a plus.
• Prior internship or co-op in medical devices is a plus.

Responsibilities

• Write and maintain a project plan with milestones and review progress weekly.
• Meet with department heads to identify and prioritize SOPs for training.
• Create 5–10 knowledge check quizzes and roll them out in Arena for SOP retraining.
• Review pFMEAs with production leads to identify high-risk operations.
• Define methods to evaluate training effectiveness for operators.
• Draft a work instruction for the training effectiveness process.
• Coordinate with suppliers to obtain updated quality questionnaires and certificates.
• Request REACH and RoHS documentation to support EU MDR requirements.
• Escalate gaps or nonconforming findings to the Quality team.
• Present projects and results to the team at summer’s end.

Skills

Quality systems

Attention to detail

Communication

Project coordination

Self-motivated

ISO 13485 familiarity

Education

Bachelor's degree in engineering

Job description

Lexington Medical, Inc. in Bedford, MA seeks a Quality Systems Engineering Intern to drive three real projects, from training program development to supplier documentation updates.

You’ll work closely with Quality, Regulatory, Production, and department leaders to implement SOPs and assess training effectiveness. The role offers hands-on experience in medical-device quality systems, pFMEAs, and EU MDR documentation, preparing you for a career in quality engineering within a fast-paced