Quality Engineer III - NPD & Validation Expert

MESO SCALE DIAGNOSTICS, LLC.; Maryland; On-site; USD 101,000 - 155,000; Full time

Benefits offered by this job

401(k) match

Medical, dental, vision coverage

Paid vacation and holidays

Job summary

MESO Scale Diagnostics, LLC. seeks an experienced Quality Engineer III to lead QMS-driven activities across development, validation, and manufacturing. You will mentor junior QA staff, ensure regulatory compliance, and drive continuous improvement.

You will review design control deliverables, oversee risk management, and coordinate supplier quality for new product introductions, audits, and CAPA initiatives. Strong analytical and documentation skills are essential.

Qualifications

• Bachelor’s degree in a technical/scientific/engineering discipline required.
• Master’s degree preferred.
• 7+ years in medical devices, in vitro diagnostics, pharmaceuticals or related industry with increasing responsibility.
• Experience with developing, implementing and maintaining Quality System compliance is preferred.
• Experience planning and implementing quality plans and programs is preferred.
• ASQ certification (e.g. CQE, CRE, CQA) beneficial.

Responsibilities

• Lead New Product Development (NPD) project teams and ensure QMS compliance.
• Oversee design history files and risk management files; manage supplier activities for NPD.
• Serve as Quality representative on validation activities and support Master Validation Plan.
• Lead CAPA programs and QMS continuous improvement projects; ensure timely actions.
• Analyze data and run hypothesis tests, normal distribution and process capability analyses.
• Lead supplier quality investigations and audits; support external audits and regulatory certifications.

Skills

Quality Assurance

Leadership

Statistical Analysis

Problem Solving

Documentation

MS Office

Communication

Project Management

Education

Bachelor’s degree in technical/scientific/engineering

Master’s degree preferred

Job description

MESO Scale Diagnostics, LLC. seeks an experienced Quality Engineer III to lead QMS-driven activities across development, validation, and manufacturing. You will mentor junior QA staff, ensure regulatory compliance, and drive continuous improvement.

You will review design control deliverables, oversee risk management, and coordinate supplier quality for new product introductions, audits, and CAPA initiatives. Strong analytical and documentation skills are essential.