Quality Assurance Manager — ISO/FDA Compliance & Audits

Default (MSD); Rockville (MD); On-site; USD 125,000 - 169,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) plan with company matching

Paid vacation

Paid holidays

Job summary

MSD in Rockville, MD is seeking a Quality - Compliance leader responsible for developing, implementing and maintaining quality systems and regulatory programs in line with corporate policies and certifications.

The role manages internal audits, supplier quality, CAPA, complaints and field actions, driving continuous improvement, SOPs, staff development and timely audit execution. Travel up to 30% may be required.

Qualifications

• Bachelor’s degree in life sciences or engineering is required.
• Eight+ years of supplier quality and internal auditing experience in ISO/FDA QSR environments.
• Experience with FDA and/or ISO auditors is required.
• Two years of management experience.

Responsibilities

• Maintain and improve the quality management system to stay compliant with policies and regulations.
• Lead internal audits, supplier quality, customer audits, CAPA, complaints and field actions.
• Establish and monitor staff performance, objectives, and development.
• Develop and implement SOPs and ensure timely audit execution.
• Promote continuous improvement and quality culture.

Skills

Internal audits

Supplier quality

CAPA

Audit leadership

MS Office

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

ASQ CQE/CRE/CQA

Job description

MSD in Rockville, MD is seeking a Quality - Compliance leader responsible for developing, implementing and maintaining quality systems and regulatory programs in line with corporate policies and certifications.

The role manages internal audits, supplier quality, CAPA, complaints and field actions, driving continuous improvement, SOPs, staff development and timely audit execution. Travel up to 30% may be required.