Senior Quality Engineer, NPD, Validation & Compliance

Meso Scale Diagnostics LLC; Rockville (MD); On-site; USD 101,000 - 155,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) matching

Paid vacation

Job summary

Meso Scale Diagnostics LLC seeks a Quality Engineer III to lead QA activities and mentor junior staff in Rockville, MD. The role drives design controls, validation strategies, and continual improvement within MSD's Quality System, ensuring compliance with QSR/ISO standards and regulatory certifications.

You will direct CAPA programs, audits, and supplier quality investigations, while collaborating across NPD and manufacturing to uphold product quality and regulatory readiness.

Qualifications

• Bachelor's degree in a technical/scientific/engineering discipline required.
• Minimum of 7 years of experience in medical devices, in vitro diagnostics, pharmaceuticals or related industry.
• Experience with developing, implementing and maintaining Quality System compliance strongly preferred.
• Experience planning and implementing quality plans and programs preferred.
• Relevant ASQ Certification (e.g. CQE, CRE, CQA) is beneficial.

Responsibilities

• Participate on New Product Development (NPD) project teams.
• Review deliverables of the design and development process for conformity to requirements.
• Oversee design history files and risk management files.
• Oversee supplier management activities for NPD projects.

Skills

Quality systems

Analytical skills

Communication skills

MS Office

Problem solving

Education

Bachelor's degree in technical/scientific/engineering

Master's degree

Tools

MS Office Suite

Job description

Meso Scale Diagnostics LLC seeks a Quality Engineer III to lead QA activities and mentor junior staff in Rockville, MD. The role drives design controls, validation strategies, and continual improvement within MSD's Quality System, ensuring compliance with QSR/ISO standards and regulatory certifications.

You will direct CAPA programs, audits, and supplier quality investigations, while collaborating across NPD and manufacturing to uphold product quality and regulatory readiness.