12 days old

Senior QA Engineer, Digital Services Technology

GE Energy
Waukesha, WI 53188
Role Summary:This position is responsible for providing quality assurance process support to GE Healthcare Digital Service Technology (DST) organization in accordance with GE Healthcare ISO9001 Quality Management System (QMS). He/she develops the strategy for program teams to meet compliance requirements and is responsible for the development, implementation and improvement of QA practices. The role may involve work in design, design transfer, manufacturing, distribution, and service.

Essential Responsibilities:



+ Establishes and maintains ISO 9001 certifications in conjunction with other Quality Leaders; manages regular QMS audit and develop common audit platform.



+ Manages QMR (Quality Management Review) operating mechanism and supports continuous product and process improvement through identifying major site quality risks and product quality metrics; leverages metrics to assist in shaping the strategy of the assigned area of responsibility.



+ Maintains ISO9001 processes and guidelines to standardize quality assurance activities and good practices; ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.



+ Works with engineering teams closely to drive quality excellence of DST products, including DHF documents review, product quality metrics defining and review, design reviews, processes/practices simplification, QMS training, etc.



+ Improves process simplification by migrating all teams to ISO9001 QMS; assists with initial quality gap analyses to ISO9001 QMS and implements risk-based approach to remediation.



+ Leads, develops, & implements quality strategy for DST and provides regular updates to senior leadership.



+ Enables service and customer productivity, manages commercialization of offerings, and manages quality dashboard integrations.



+ Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.



+ May be responsible for migration to ISO 13485 QMS when non-medical device products convert to medical device.





Qualifications/Requirements:



+ Minimum of a Bachelor's Degree in Engineering, Computer Science or equivalent



+ Minimum 8 years experience in Quality Assurance / Regulatory Affairs



+ Minimum 5 years experience in healthcare digital technology and software



+ Strong leadership skills and have extensive experiencing managing programs/projects; be able to work horizontally with all functions within the organization and exerts strong influence to achieve desirable outcomes.



+ Experience leading/performing internal audits and participating in external audits.





+ Practical knowledge of software development and familiarity with Software Development Lifecycle (SDLC)



+ Ability to effectively communicate technical information in English (both written and oral).





Desired Characteristics:



+ Familiarity with medical device or ISO9001 healthcare software development environment with experience of regulatory audits.



+ Familiarity with Agile/Lean software development lifecycle process. ScrumMaster experience is preferred.



+ Demonstrated understanding or aptitude to understand ISO9001 or Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.



+ Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management.





+ Demonstrated collaboration, negotiation & conflict resolution skills





+ Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance



+ Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing.



+ Experience in a globalized working environment.



+ Experience leading and implementing change.



+ Ability to multi-task & handle tasks with competing priorities effectively.





+ Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.





About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GEs mission and deliver for our customers. www.ge.com

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.

Additional Eligibility Qualifications:GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).Additional Locations:United States;Wisconsin;Waukesha;

Categories

Posted: 2020-10-13 Expires: 2020-11-12

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Senior QA Engineer, Digital Services Technology

GE Energy
Waukesha, WI 53188

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast