QA & Compliance Leader - ISO/FDA Audits & CAPA

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

Benefits offered by this job

Health coverage

Dental coverage

Vision coverage

401(k) with match

Paid vacation

Paid holidays

Paid parental leave

Disability insurance

Life insurance

Employee assistance program

Fitness club membership

Pet insurance

Identity protection

Insurance discounts

Supplemental life

Job summary

MESO SCALE DIAGNOSTICS, LLC. seeks a Quality Systems and Compliance leader to develop and maintain quality programs tied to corporate policies and regulatory certifications. You will drive internal audits, CAPA, supplier quality, and field actions while leading a team to uphold ISO and FDA requirements.

You will establish SOPs, monitor CAPA effectiveness, and coordinate with external audits, ensuring timely corrective actions and a culture of continuous improvement.

Qualifications

• Bachelor’s Degree in Life Sciences or Engineering is required.
• Minimum of eight years of experience in supplier quality and internal auditing in an ISO or FDA QSR environment.
• Experience working with FDA and/or ISO auditors is required.
• Two years of management experience required.
• ASQ certification (CQE, CRE, CQA) is strongly preferred.

Responsibilities

• Maintain and improve quality management system and ensure compliance with policies and regulations.
• Lead internal audits, supplier quality, customer audits, CAPA, complaints and field actions.
• Establish staff performance goals, assign accountabilities and provide feedback.
• Promote a culture of high performance and continuous improvement.
• Develop, revise and implement SOPs and ensure timely audit execution.
• Oversee supplier audits and evaluate suppliers for conformance.
• Participate in external audits and customer audits.

Skills

ISO 13485

ISO 9001

Internal audit

Supplier quality

CAPA management

Leadership

FDA/ISO auditing

Problem solving

Communication

Education

Bachelor's degree in Life Sciences or Engineering

Tools

MS Office Suite

Job description

MESO SCALE DIAGNOSTICS, LLC. seeks a Quality Systems and Compliance leader to develop and maintain quality programs tied to corporate policies and regulatory certifications. You will drive internal audits, CAPA, supplier quality, and field actions while leading a team to uphold ISO and FDA requirements.

You will establish SOPs, monitor CAPA effectiveness, and coordinate with external audits, ensuring timely corrective actions and a culture of continuous improvement.