What are the responsibilities and job description for the Quality Engineer position at IZiel Healthcare?
Role: Quality Engineer
Location: North Haven, CT
- STRONG PLUS: TMV, MSA, process development and PFMEA.
- MUST HAVE: Hands-on equipment/process validation; process development/statistical analysis; IQ/OQ/PQ execution and reporting; QMS.
Role summary
- IZiel seeks a quality engineer to support defined Project Odyssey engineering work packages associated with the installation, relocation, commissioning, process development and validation of manufacturing equipment. The role will work with Medtronic stakeholders and IZiel’s broader engineering team. Specific work packages will be assigned according to project priorities and the candidate’s capabilities.
Technical qualifications
- Manufacturing process and automation design fundamentals
- Process development, statistical analysis and equipment validation
- Quality management systems and validation documentation
- DFA, PFMEA, IQ, MSA, OQ and PQ
Project responsibilities
- Plan and execute assigned equipment and process validation work packages.
- Develop or review IQ/OQ/PQ protocols, TMV, validation reports and associated quality documentation.
- Support process development, risk assessments, discrepancy investigations and resolution.
- Coordinate evidence, review and approval readiness with Medtronic stakeholders and IZiel engineering colleagues.
Preferred experience
- Strong hands-on validation experience in medical-device manufacturing; comfortable working with equipment, protocols and multidisciplinary teams.
Education
Mechanical Engineering, Mechatronics or equivalent technical degree.
Working model
Work onsite in North Haven as required for equipment access, execution and coordination. Collaborate with IZiel’s offshore engineering team on appropriate technical analysis, protocols and documentation. Actual onsite allocation, project duration, start date and reporting structure will be confirmed during staffing.