What are the responsibilities and job description for the Quality Engineer position at Pentangle Tech Services | P5 Group?
Job Description
- Knowledge of Medical procedure and corresponding Medical Equipment
- Good experience in CAPA execution, CAPA write-up
- Good experience in Test Method Validation (TMV)
- Good experience in Process Validation.
- Knowledge of Medical Equipment manufacturing processes
- Knowledge on Quality Management and its tools & techniques
- Knowledge about FDA, ISO 13485, ISO 14971 and compliance regulations
- Knowledge on NC, Audit processes
- Knowledge in Statistic, Risk Management and Design control
- Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills
- A minimum with 5 years of related experience Quality Management in Medical Device Industry.
- Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
- Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development.
- Non-Conformance Report (NCR) process for Sterilmed business unit.
- Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.
- Write, review and/or approve process and product validation protocols and reports, engineering change orders.
- Use statistical tools to analyze data, make acceptance decisions, and improve process capability, Design Controls, Design of Experiments
- Technical problem solving, failure analysis, and root cause determination.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Strong communication skills