About the Role
The individual in this role will support quality systems by conducting audits, analyzing data, and implementing improvements to ensure adherence to specifications and regulatory standards.
Responsibilities
- Conduct product and process audits to verify compliance with quality standards
- Analyze non-conformance reports and recommend corrective actions
- Support validation of manufacturing processes and equipment
- Collaborate with cross-functional teams to resolve quality issues
- Develop and maintain quality control documentation
- Monitor production for deviations from established specifications
- Assist in root cause investigations for product defects
- Ensure compliance with ISO and regulatory requirements
- Review batch records and quality data for accuracy
- Implement continuous improvement initiatives in quality processes
- Participate in risk assessment activities
- Support supplier quality performance evaluations
- Track key quality metrics and report trends
- Lead or contribute to internal audit programs
- Verify effectiveness of corrective and preventive actions
- Assist in product design reviews from a quality perspective
- Ensure proper handling and disposition of non-conforming materials
- Maintain calibration and maintenance records for quality equipment
- Support regulatory inspections and audits
- Train personnel on quality procedures and standards
- Use statistical methods to evaluate process capability
- Ensure traceability throughout the production lifecycle
- Work with R&D to transition new products into manufacturing
- Document deviations and ensure timely resolution
- Promote a culture of quality and compliance
Compensation
Competitive salary and benefits package offered
Work Arrangement
Hybrid work model with on-site and remote options
Team
Part of a global quality assurance team focused on product integrity
About the Team
This role is embedded within a multidisciplinary group dedicated to maintaining product quality across diverse production environments.
Additional Information
- Candidates must be legally authorized to work in the United States without sponsorship limitations in the future.
- This position may involve occasional travel to manufacturing or supplier sites.
This position may require sponsorship for employment visa status
