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Quality Engineer

4 months ago

Irvine, United States Katalyst HealthCares & Life Sciences Full time

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