Software Validation Expert

hace 2 días


Alajuela, Alajuela, Costa Rica Microvention, Inc. A tiempo completo
Job Overview
The Software Validation Engineer II plays a crucial role in ensuring the quality and integrity of software validation processes for Quality Management Systems or Production Software. This position involves executing and assisting in software validation and revalidation efforts, working closely with various teams to test software provided by vendors or in-house.

Responsibilities
Generate project plans to identify strategies, roles, and responsibilities, resource requirements, key milestones, and timelines for software validation projects.
Follow established software validation procedures to accomplish software validation or revalidation for Quality Management Systems (QMS) or Production Software (Equipment or Non-Equipment).
Collaborate with business process owners to develop specifications for systems that meet business requirements.
Work closely with different teams involved to test software provided by vendors or in-house to verify it works as intended.
Generate master validation plans for software projects.
Generate/assist with risk assessments for software projects.
Generate, execute, and/or review SW validation protocols (operation/performance qualification protocols) and reports (verifies test cases are adequate, verifies executed protocols for GDP, etc.).
Coordinate user acceptance testing (UAT) activities and execution of validation protocols.
Generate software data migration plans and reports.
Generate software retirement plans and reports.
Assist with code review and unit testing reports.
Assist with training material and work instructions for users.
Manage completion of projects per SW validation master plans and ensure timely completion.
Serve as a PM for software validation projects.
Derive solutions to challenges and escalate any issues as they are identified.
Provide expertise to SW owners regarding identifying required level of validation for SW items.

Requirements
- Bachelor's degree in Engineering or other relevant discipline or equivalent experience.
- Two (2) or more years of experience.
- Demonstrated experience in medical device manufacturing SW.
- English proficiency both written and verbal (80-85%).
- Working knowledge of General Principles of Software Validation; Final Guidance for Industry and FDA Staff (GPSV).
- Knowledge of 21CFR11, 21CFR820, and ISO 13485.

Preferred Qualifications
- Ability to translate regulation requirements into practical validation plans.
- Ability to write and review SW validation documentation (validation plan, risk assessment, user/functional requirements, protocols, reports, etc.).
- Keep abreast with regulatory requirements related to QMS software and production (non-equipment or equipment) software.
- Successful experience working independently, effectively, and confidently in a team environment.
- Ability to present SW validation strategies and obtain alignment from stakeholders (i.e., upper management).
- Ability to determine the required test cases during SW validation.
- Demonstrated skills in developing risk-based master validation plans, test protocols, and preparing test reports.
- Knowledge of medical device software regulations, including requirements for electronic records and electronic signatures.
- Ability to work with multiple associates and prioritize projects to meet deadlines.
- Shows strong decision-making and problem-solving skills.
- Excellent written and verbal communication skills.
- Proficient with MS Project, Word, Excel, and Outlook.

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