Quality Engineering Manager — Design Control & QMS Leader

MESO SCALE DIAGNOSTICS, LLC.; Washington, Tacoma (District of Columbia, WA, MD); On-site; USD 117,000 - 178,000; Full time

Benefits offered by this job

401(k) with company matching

Paid vacation

Paid holidays

Paid parental leave

Disability insurance

Group life insurance

Job summary

Meso Scale Diagnostics, LLC in the United States is seeking a senior leader to develop, implement, and maintain the design and development program within the quality management system.

This role leads the quality engineering team, drives design control for new products and changes, and ensures compliance with ISO 13485 and FDA expectations while supporting cross‑functional product development.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Biochemistry or Engineering.
• Minimum of eight years in a quality role supporting design control for multiple product types.
• Experience with FDA and/or ISO auditors preferred.
• Minimum of 2 years of management experience.

Responsibilities

• Maintain and continuously improve the design and development elements of the QMS and ensure compliance.
• Establish and monitor staff performance, set objectives and provide feedback.
• Promote a high performance culture focused on quality.
• Manage quality engineering team providing design control guidance for new products and changes.
• Develop, implement and maintain SOPs for the Design Control program.
• Manage product development and enhancement activities.
• Contribute to hardware, software and assay requirements for new products.
• Collaborate with cross‑department teams to support design, development, integration, transfer, production and after‑sales support.
• Duties may vary depending on departmental requirements.

Skills

ISO 13485 knowledge

Design controls

Mentoring teams

Leadership

Problem solving

Communication

MS Office Suite

Negotiation & mediation

Attention to detail

Education

Bachelor’s degree in Biology, Chemistry, Biochemistry or Engineering

Tools

MS Office Suite

Job description

Meso Scale Diagnostics, LLC in the United States is seeking a senior leader to develop, implement, and maintain the design and development program within the quality management system.

This role leads the quality engineering team, drives design control for new products and changes, and ensures compliance with ISO 13485 and FDA expectations while supporting cross‑functional product development.