What are the responsibilities and job description for the Quality Engineer (Medical Devices) position at TekHawks?
Hiring: Quality Engineer
Location: Warsaw, Indiana
Duration: Contract
Job Type: W2
We are looking for an experienced Quality Engineer to support quality assurance and continuous improvement activities in a regulated manufacturing environment.
Key Responsibilities:
- Support quality management system (QMS) activities and maintain quality documentation.
- Investigate nonconformances, perform root cause analysis, and support CAPA.
- Review and maintain quality records, procedures, and work instructions.
- Support internal and external audits and ensure compliance with applicable quality standards.
- Collaborate with Manufacturing, Engineering, and Supplier Quality teams to resolve quality issues.
- Monitor quality metrics and drive continuous improvement initiatives.
- Support risk management, process validation, and corrective/preventive actions as applicable.
Required Qualifications:
- Experience in Quality Engineering within a manufacturing environment.
- Knowledge of CAPA, RCA, nonconformance management, and quality documentation.
- Familiarity with ISO 13485, FDA regulations, or ISO 9001 preferred.
- Strong problem-solving, analytical, and communication skills.
- Medical device manufacturing experience is a plus.
Salary : $45 - $55