About the Role
This role is responsible for supporting quality systems in a production environment, identifying defects, driving corrective actions, and ensuring adherence to regulatory requirements.
Responsibilities
- Monitor manufacturing processes to ensure compliance with quality standards
- Conduct root cause analyses for product and process non-conformances
- Support internal and external quality audits
- Collaborate with cross-functional teams to resolve production issues
- Develop and maintain quality documentation
- Implement corrective and preventive actions (CAPA)
- Track and report key quality performance metrics
- Perform inspections and testing on raw materials and finished goods
- Work with suppliers to improve component quality
- Lead quality improvement projects across production lines
- Ensure compliance with ISO and FDA regulations
- Assist in new product introductions from a quality perspective
- Review and approve manufacturing work instructions
- Investigate customer complaints and field failures
- Support continuous improvement methodologies such as Lean or Six Sigma
- Maintain calibration and measurement systems
- Train production staff on quality procedures
- Evaluate process changes for quality impact
- Participate in design for manufacturability reviews
- Ensure proper handling of non-conforming materials
- Support regulatory submissions with quality data
- Drive supplier quality performance through audits and scorecards
- Use statistical tools to analyze quality trends
- Maintain the quality management system documentation
- Ensure traceability throughout the production lifecycle
Compensation
Competitive salary and benefits package
Work Arrangement
Onsite
Team
Part of the manufacturing and quality assurance team focused on product reliability and compliance
Why This Role Matters
- Quality engineers play a critical role in ensuring products meet safety, reliability, and regulatory standards before reaching customers.
- This position directly influences product excellence and customer satisfaction through proactive quality management.
What We Look For
- Candidates should demonstrate a strong commitment to quality, analytical thinking, and the ability to influence cross-functional teams.
- We value individuals who take initiative and drive improvements in complex environments.
Available for qualified candidates
