Quality Assurance Leader: Audits, CAPA & Compliance

Meso Scale Diagnostics LLC; Rockville (MD); On-site; USD 117,000 - 178,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) with company matching

Life Insurance

Disability Insurance

Paid vacation

Paid holidays

Parental leave

Employee assistance program

Job summary

Meso Scale Diagnostics LLC seeks a senior quality leader to develop, implement, and maintain quality systems and compliance programs aligned with corporate policies and active regulatory certifications. You will oversee internal audits, supplier quality, CAPA, complaints and field actions to sustain high performance.

Responsibilities include SOP development, audit scheduling, staff development, and driving continuous improvement across the QMS in a fast-paced production environment.

Qualifications

• Bachelor's degree in life sciences or engineering required.
• Minimum eight years in supplier quality and internal auditing in ISO or FDA QSR.
• Experience with FDA and/or ISO auditors required.
• Two years of management experience required.
• ASQ CQE/CRE/CQA strongly preferred.

Responsibilities

• Maintain and continually improve the quality management system to stay compliant with company policies and regulatory requirements.
• Lead internal audits, supplier quality, CAPA, complaints and field actions.
• Develop SOPs and monitor audit schedules and CAPA effectiveness.
• Establish staff performance goals and provide ongoing feedback and development.
• Oversee customer audits and supplier evaluations, including supplier audit schedules.

Skills

Quality management

Auditing

CAPA

Supplier quality

Leadership

Communication

Problem solving

MS Office

Regulatory knowledge

Education

Bachelor's Degree in Biology, Chemistry, Biochemistry or Engineering

ASQ certification (CQE, CRE, CQA)

Job description

Meso Scale Diagnostics LLC seeks a senior quality leader to develop, implement, and maintain quality systems and compliance programs aligned with corporate policies and active regulatory certifications. You will oversee internal audits, supplier quality, CAPA, complaints and field actions to sustain high performance.

Responsibilities include SOP development, audit scheduling, staff development, and driving continuous improvement across the QMS in a fast-paced production environment.