We are seeking a detail-oriented Quality Engineer to support quality assurance activities across manufacturing and/or product development environments. The ideal candidate will ensure compliance with regulatory standards, improve process quality, and support validation and continuous improvement initiatives.
Key Responsibilities
- Develop, implement, and maintain Quality Management System (QMS) processes
- Support CAPA, deviation investigations, and root cause analysis
- Participate in internal audits and external regulatory inspections
- Review and approve quality documentation (SOPs, protocols, reports)
- Ensure compliance with ISO 9001 / ISO 13485 / GMP / FDA regulations (as applicable)
- Support process validation, equipment qualification (IQ/OQ/PQ) activities
- Collaborate with cross-functional teams including Manufacturing, R&D, and Regulatory
- Monitor quality metrics and drive continuous improvement initiatives
- Assist with supplier quality management and audits
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 2+ years of experience in quality engineering or quality assurance
- Strong knowledge of QMS, CAPA, and root cause analysis tools
- Experience with GMP / FDA / ISO standards
- Familiarity with validation documentation and change control processes
Job Type: Contract
Pay: $30.61 - $44.09 per hour
Benefits:
Work Location: In person