Quality Manager - #1403788
Culmen International
Date: 2 days ago
City: Frederick, MD
Contract type: Full time
Culmen International is looking for a Quality Manager to support a USAMRIID program at Fort Detrick, MD.
The Quality Manager leads implementation of quality assurance programs and ensures that laboratory operations and documentation meet GLP, ISO, and DoD regulatory requirements.
What You’ll Do In Your New Role
Culmen International is committed to enhancing international safety and security,
strengthening homeland defense, advancing humanitarian missions, and optimizing government operations. With experience in over 150 countries, Culmen supports our clients to accomplish critical missions in challenging environments.
At Culmen International, we are committed to creating and sustaining a workplace that upholds the principles of Equal Employment Opportunity (EEO). We believe in the importance of fair treatment and equal access to opportunities for all employees and applicants. Our commitment to these principles is unwavering across all our operations worldwide.
The Quality Manager leads implementation of quality assurance programs and ensures that laboratory operations and documentation meet GLP, ISO, and DoD regulatory requirements.
What You’ll Do In Your New Role
- Develop, implement, and monitor quality control processes.
- Conduct internal audits and corrective action reviews.
- Train personnel on QA policies and GLP principles.
- Maintain SOPs and QA/QC documentation systems.
- Coordinate inspections and regulatory reporting.
- Bachelor’s degree in quality assurance, regulatory science, or life sciences.
- 8+ years in quality systems in biomedical or regulatory environments.
- Knowledge of GLP, ISO 9001/13485, and FDA/DoD regulations.
- Strong auditing and root cause analysis skills.
- Experience with CAPA and deviation management.
- Excellent leadership and process improvement skills.
- Must be able to obtain and maintain a DoD Secret clearance and enroll in the Personnel Reliability Program (PRP), if required.
- ASQ CQE/CQA certification or advanced degree preferred.
Culmen International is committed to enhancing international safety and security,
strengthening homeland defense, advancing humanitarian missions, and optimizing government operations. With experience in over 150 countries, Culmen supports our clients to accomplish critical missions in challenging environments.
- Exceptional Medical/Dental/Vision coverage with 100% of the premiums paid by the company for all eligible employees and their eligible dependents (including same or opposite sex domestic partners)
- 401k – Vested immediately and 4% match
- Life insurance and disability paid by the company
- AFLAC Available
- Opportunities for Training and Continuing Education
- 12 Paid Holidays
At Culmen International, we are committed to creating and sustaining a workplace that upholds the principles of Equal Employment Opportunity (EEO). We believe in the importance of fair treatment and equal access to opportunities for all employees and applicants. Our commitment to these principles is unwavering across all our operations worldwide.
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