天津招聘

General: Software Quality Assurance Engineer

KEY AREAS OF RESPONSIBILITIES

· Responsible for Software quality engineering activities like: Designing SW Quality plans, overseeing the execution of SW Quality Plans, assessing complex software designs and reviewing test and other complex performance data, lead complex root cause analysis and complex SW Quality problem solving.      

· Responsible for Architecture and Platform Creation and Product Development Launch and Maintenance (AnPC and PDLM) process deployment from corporate to local QMS

· Support and facilitate the department in enabling and assuring that products are developed and produced in compliance with requirements from applicable standards  (ISO13485, IEC62304, ISO14971)

· Give guidance and actively contributes to all aspects related to quality, applicable regulatory requirements and Philips policies and procedures

· Make a substantial contribution to ways of combining Scaled Agile with medical software development

· Responsible for Non-Production Software System validation process planning and execution and ensure the compliant validation of all SW systems in QMS scope.

OTHER RESPONSIBILITIES

· Supports (local) Q&R processes, including quality training, internal & external audit and CAPA, Quality Management Review, as a representative of Software Quality Assurance.

· Manages the transition of the PQMS/PEPF and manage its deployment.

· Supporting quality system integration and improvements, as a representative of Software Quality Assurance.

Must have items:

- >2 years Q&R role, preferably in a Software Development Quality Assurance Role

- Experienced in Scaled Agile is a must

- Knowledge of applicable Software Product Lifecycle management and QMS standards (ISO9001:2015)

- Team player, pragmatic, pro-active, English speaking/reading/writing.

Nice to have items:

- Knowledge of applicable Medical Device Software Product Lifecycle and QMS standards (ISO62304, ISO13485:2016, ISO14971)

微信分享