Quality Assurance Leader - ISO/FDA Audits & CAPA

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

Benefits offered by this job

Medical, dental, vision coverage

401(k) plan with company matching

Paid vacation

Paid holidays

Disability insurance

Life insurance

Parental leave

Employee assistance program

Fitness club membership contribution

Pet insurance

Identity theft protection

Insurance discounts

Job summary

Meso Scale Diagnostics, LLC. is seeking a Senior Quality Manager to develop, implement, and maintain quality systems and compliance programs across the organization. You will oversee internal audits, supplier quality, CAPA, complaints and field actions, ensuring adherence to ISO 13485 and FDA QSR requirements.

The role also requires leadership over staff performance, SOP development, and continuous improvement initiatives in a high-demand production environment.

Qualifications

• Bachelor’s Degree in Biology, Chemistry, Biochemistry or Engineering.
• Minimum of eight years in supplier quality and internal auditing in ISO or FDA QSR environments.
• FDA and/or ISO audit experience required.

Responsibilities

• Maintain and improve the quality management system and ensure regulatory compliance.
• Lead internal audits, supplier quality, customer audits, CAPA, complaints and field actions.
• Develop and implement SOPs and monitor audit schedules.

Skills

ISO knowledge

ISO 13485

ISO 9001

Auditing

CAPA

Leadership

Communication

Problem solving

Negotation/ mediation

MS Office

Education

Bachelor’s Degree in Life Sciences or Engineering

Job description

Meso Scale Diagnostics, LLC. is seeking a Senior Quality Manager to develop, implement, and maintain quality systems and compliance programs across the organization. You will oversee internal audits, supplier quality, CAPA, complaints and field actions, ensuring adherence to ISO 13485 and FDA QSR requirements.

The role also requires leadership over staff performance, SOP development, and continuous improvement initiatives in a high-demand production environment.