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Work with cross-functional teams to establish project goals, objectives, milestones, quality plans, risk management plans, and associated quality documentation for software related projects.
Participate in design reviews and the entire Software Development Life Cycle (SDLC) to ensure activities follow design control, software development, software testing comply with applicable procedures and standards.
Direct Failure Mode and Effects Analysis and/or Fault Tree Analysis for software systems.
Develop, review, and/or approve verification and validation (V&V) protocols and reports for off-the-shelf software, configured software, custom software, and equipment with software.
Execute and/or manage the execution of V&V protocols.
Ensure Standard Operating Procedures (SOP’s), Work Instructions (WI’s), templates, and related Quality documents are in place and effective to comply with external regulations and standards.
Develop new and improve existing SOP’s, WI’s, and templates related to software risk management, SDLC, and V&V.
Adhere to SOP’s and WI’s to ensure compliance with internal procedures and external regulations.
Effectively manage multiple tasks and projects with minimal supervision.
Other duties as assigned.
EDUCATION & TRAINING
Bachelor’s degree in Computer Science, Engineering, or related discipline or equivalent combination of education/experience.
American Society for Quality (ASQ) or related certification is preferred.
Experience in software development lifecycle such as design documentation, process models, process decomposition diagrams, data models, data flow diagrams, entity relationship diagrams, and network diagrams.
Minimum of 5 years of hands-on experience in developing and executing test plans for white/black box testing, test cases, and test reports.
Minimum of 5 years of hands-on experience with regression, unit, integration, and post implementation testing.
Experience in developing and improving Quality documentation such as Standard Operating Procedures, Work Instructions, V&V templates, forms, etc.
Familiar with various operating systems (Windows, DOS, UNIX, and Linux) is a plus.
Relevant experience in a medical device manufacture or related biotech company is a plus.
In-depth knowledge of software QA, design control, and verification & validation tools, methodologies, and regulations.
In-depth knowledge of GMP and QSR requirements for medical device manufacturers.
Ability to develop, implement, and improve Quality procedures and standards.
Excellent verbal and written communication skills.
Strong interpersonal skills with the ability to work collaboratively in cross-functional project teams.
Ability to effectively communicate with personnel across all levels of the organization.
Strong organizational skills with the ability to effectively multitask and manage multiple assignments with minimal supervision.
Ability to learn quickly and work independently.
Strong analytical skills to effectively and efficiently resolve problems of varying complexity.
Proficient in Microsoft Office especially in Word and Excel.
Ability to read and understand software code is preferred.
Understanding of RDBMS and a working knowledge of SQL is preferred.
Working knowledge of manufacturing, online ordering, distribution, and warehouse systems is preferred.