Quality Engineer - Katalyst Healthcares & Life Sciences
IRVINE, CA 92602
About the Job
Responsibilities:
- 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.
- Oversight, from a Quality NPD perspective, of the Non-Conformance Report (Client) process for BWI facilities located in the U.S.
- 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 (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.).
- Performs statistical analysis of data generated including but not limited to: Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria.
- Ensure that development activities follow design control requirements (Design Trace Matrix).
- Technical problem solving, failure analysis, and root cause determination.
- Makes decisions independently on engineering problems and methods and represents the organization.
- Recommend issue resolution to management for significant capability and compliance issues.
- Works closely with functional leadership in planning and executing project milestones.
- Carries out complex or Client assignments requiring the development of new or improved techniques or procedures.
- Assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment, when necessary, data are insufficient or confirmation by testing is advisable.
- Responsible for communicating business related issues or opportunities to next management levels.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Requirements:
- Knowledge of Medical procedure and corresponding Medical Equipment
- 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 Medical Device Regulatory Standards, MDD and MDR
- Knowledge on NC, CAPA, 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
Source : Katalyst Healthcares & Life Sciences