Katalyst Healthcares and Life Sciences
Responsibilities:
- Our client is searching for a Quality Engineer to support various activities for their specimen management instruments.
- This role is critical in ensuring the ongoing quality and compliance of supplier-provided components and materials.
- The ideal candidate will work cross-functionally with internal teams and external suppliers to address quality issues, support design control and change management, and maintain a robust supplier quality system in alignment with regulatory requirements.
- Serve as the primary quality liaison for sustaining engineering efforts related to change control and design control.
- Monitor and improve supplier performance through metrics, audits, and continuous improvement activities.
- Collaborate with R&D, Manufacturing, Regulatory, and various quality teams to support design changes, material changes, and process improvements.
- Maintain documentation and records in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 1497
- Support supplier quality risk management activities, including risk assessments and periodic reviews.
- Assist with Process Validation efforts as well as give insight into the Assurance efforts on the operations team
- 5-7 years of experience in quality engineering, within the medical device industry.
- Strong analytical, problem-solving, and communication skills.
- Experience working directly with suppliers, including audit, quality agreements, and performance management.
- Familiarity with quality tools (e.g., 8D, FMEA, root cause analysis, CAPA).
- Strong cross functional communication skills.
- Strong understanding of design control and change control.