About the Role
This role is responsible for conducting thorough audits of quality systems, identifying gaps, and ensuring adherence to applicable regulations and company policies across multiple sites.
Responsibilities
- Perform internal and supplier audits to verify compliance with FDA, ISO, and other regulatory requirements.
- Evaluate documentation practices for accuracy, completeness, and traceability.
- Assess manufacturing processes for alignment with quality standards and specifications.
- Identify non-conformances and recommend corrective actions to mitigate risks.
- Collaborate with quality engineers to verify effectiveness of implemented improvements.
- Maintain detailed audit records and prepare comprehensive reports.
- Support regulatory inspections by providing documentation and subject matter expertise.
- Track audit findings and verify closure of corrective and preventive actions.
- Participate in continuous improvement initiatives for quality systems.
- Train personnel on audit expectations and quality compliance principles.
- Review change controls and deviations for potential quality impacts.
- Ensure audit programs align with current industry standards and regulations.
- Conduct risk-based assessments to prioritize audit focus areas.
- Work with external auditors during third-party assessments.
- Support quality system readiness for new product launches.
- Evaluate supplier performance through on-site and remote audit methods.
- Maintain up-to-date knowledge of regulatory changes affecting quality compliance.
- Coordinate audit schedules across multiple departments and locations.
- Promote a culture of quality and compliance across the organization.
- Use data analytics to identify trends and recurring quality issues.
- Ensure audit processes follow established standard operating procedures.
- Participate in cross-functional teams to resolve systemic quality problems.
- Report audit metrics to management for performance evaluation.
- Support quality audits in both domestic and international facilities.
- Contribute to the development of audit checklists and assessment tools.
Compensation
Competitive salary and benefits package commensurate with experience.
Work Arrangement
Full-time, on-site position with limited remote flexibility based on operational needs.
Team
Part of the Global Quality Assurance team, collaborating with cross-functional departments including manufacturing, regulatory affairs, and quality systems.
Why This Role Matters
This position plays a critical role in maintaining product integrity and ensuring compliance with global regulatory standards, directly contributing to patient safety and company reputation.
What You’ll Need to Succeed
Success in this role requires a combination of technical expertise, analytical thinking, and the ability to communicate effectively with diverse teams across functions and geographies.
Work Environment
The role operates in a dynamic, fast-paced environment with exposure to manufacturing floors, laboratories, and office settings, requiring adherence to safety and hygiene protocols.
Growth Opportunities
Opportunities exist for professional development in quality leadership, regulatory strategy, and cross-functional project involvement.
Physical Demands
The position may require standing for extended periods, walking through production areas, and occasional lifting of up to 20 pounds.
Travel Requirements
Approximately 20-30% travel is expected, including visits to supplier sites and company facilities across North America and abroad.
Equal Employment Opportunity
The company provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, national origin, age, disability, or genetics.
Reasonable Accommodations
Applicants needing reasonable accommodations for any part of the application process may request assistance through the official careers portal.
May be available for qualified candidates based on business needs and eligibility.
