Global Senior QA Software Engineer - Remote

We are a Recruiting Firm and one of our best Global Medical Device Manufacturing client, is looking for an experienced Remote Global Senior QA Software Engineer who reports to the Head of Global RA QA. Position manages and communicates with senior leadership concerning all major software development quality system issues related to manufacturing, design control and compliance with applicable regulations. Can be onsite or remote. From Them: 

WHY WORK FOR US:

·        Cutting-Edge, Global Company, leader in its industry, making the world a better place

·        Company experiencing sustained health and growth

·        Excellent Compensation and Stellar Benefits.

·        Career Growth Opportunity 

WHAT YOU’LL BE DOING:

·        Achieves quality assurance global operational objectives for software systems

·        Supports the implementation and management of an SDLC (Software Development Life Cycle) Program

·        Reviews, revises and approves software protocols as required.

·        Oversees and ensures QA software compliance. Apply technical principles and methods to ensure compliance with regulatory requirements and Specialty Medical Division QMS requirements

·        Manages the implementation and maintenance of the SDLC program to ensure compliance with new and/or revised regulations.

·        Supports global and local validation activities for various software systems.

·        Facilitate incident management activities for cloud-based applications in coordination with R&D, IT, Security and Product Application Support Teams

·        Participate in and own escalation tasks and activities for software related issues

·        Supports quality data metrics analysis, trending, and reporting for monthly and quarterly management meetings

·        Provide support/responses during internal and external audits

·        Other incidental duties assigned by Leadership

·        Provides software validation training as needed to various sites and/or departments.

EXPERIENCE & SKILLS YOU’LL NEED FOR THIS POSITION:

·        Skills in management, communication, metrology

·        Knowledge of FDA GMP/regulations, ISO 13485 standard,

·        Knowledge of 93/42/EEC Medical Device Directive

·        Ability & willingness to travel 10%

·        5 years’ experience in software working within the medical devices industry

·        BS/BA or comparable experience

We look forward to speaking with you