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Senior Computer Software Validation (CSV) Engineer IRC257406
| Job | IRC257406 |
| Location | Poland - Krakow |
| Designation | Senior Test Engineer |
| Experience | 3-5 years |
| Function | Quality Assurance |
| Skills | documentation., Healthcare, Quality Management, SDLC /STLC Life cycle |
| Work Model: | Remote |
Description
A global leader in surgery with products and solutions found in almost every operating room around the world, and has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing health care issues and improve and save more lives. Through surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact.
Requirements
– At least 4-5 years of quality management work experience.
– Knowledge and understanding of ISO 9000 series and ISO 13485 standards.
– Knowledge and understanding of regulations on medical device manufacturing (at least US FDA Regulations).
– Knowledge of the software development life cycle (work experience in software development or knowledge of the international standards that regulate this process such as IEC 62304 standard).
– Experience with Software Risk Management (ISO 14971) is a big plus.
– Fundamentals of software testing and quality assurance.
– Fundamentals of FTA/FMEA/FMECA methodologies.
– Knowledge of the QMS structure.
– Experience of participation in internal and external audits.
– Strong documentation management skills.
– Ability to work with standards. Ability to comprehend a new document with standards, analyze it well enough to assess the standards’ value/benefit for the Company against possible risks entailed.
– English at the upper intermediate level.
– Presentation and training skills.
– Ability to coordinate and lead meetings in a team and with other participants.
Job Responsibilities
– Plan, schedule and organize tool validation projects.
– Interact with various stakeholders to manage and facilitate the tool validation process.
– Develop the Validation Strategy for the applications in compliance with required regulatory requirements pertaining to 21 CFR Part 11 and Annex 11.
– Author Validation Plan to document scope & purpose of validation project, roles and responsibilities, system description, intended use of the system, validation strategy, applicable regulatory framework, risk management, phases of the project, deliverables and RACI Matrix.
– Perform GxP Applicability and Criticality Assessment, Functional Risk Assessment and Audit Trail (System and Data) Risk Assessment.
– Review and approval of Specifications (User Requirement Specification, Functional Specification, Design Specification, Configuration Specification) for application.
– Review and approval of Qualification Protocols (Installation /Operational / Performance) for applications.
– Review and approval of executed Qualification Protocols (Installation / Operational / Performance) for applications.
– Author Traceability Matrix document to include the traceability of User Requirements, Functional Requirements, Design/Configuration Specifications and Qualification Protocol.
– Author Validation/Qualification Summary Reports to present, summarize and offer conclusions on the validation of the process.
– Author, review and approval of deviation reports, exceptions and non-conformance reports.
– Prepare, revise and implement relevant SOPs related to the QMS.
– Effectively communicate with other departments on quality and compliance issues.
– Participate in vendor, internal and regulatory audits.
– Participate in and lead quality and process improvement projects.
– Develop and conduct annual QMS and regulatory training
– Properly interpret and apply regulatory requirements.
– Ensure all SOPs, Forms, and Policies are in compliance with internal documentation rules and Periodic Review procedures.
We Offer
Empowering Projects: With 500+ clients spanning diverse industries and domains, we provide an exciting opportunity to contribute to groundbreaking projects that leverage cutting-edge technologies. As a team, we engineer digital products that positively impact people’s lives.
Empowering Growth: We foster a culture of continuous learning and professional development. Our dedication is to provide timely and comprehensive assistance for every consultant through our dedicated Learning & Development team, ensuring their continuous growth and success.
DE&I Matters: At GlobalLogic, we deeply value and embrace diversity. We are dedicated to providing equal opportunities for all individuals, fostering an inclusive and empowering work environment.
Career Development: Our corporate culture places a strong emphasis on career development, offering abundant opportunities for growth. Regular interactions with our teams ensure their engagement, motivation, and recognition. We empower our team members to pursue their career goals with confidence and enthusiasm.
Comprehensive Benefits: In addition to equitable compensation, we provide a comprehensive benefits package that prioritizes the overall well-being of our consultants. We genuinely care about their health and strive to create a positive work environment.
Flexible Opportunities: At GlobalLogic, we prioritize work-life balance by offering flexible opportunities tailored to your lifestyle. Explore relocation and rotation options for diverse cultural and professional experiences in different countries with our company.