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Engineer, Process Management IRC126478
| Job: | IRC126478 |
| Location: | Ukraine - Kharkiv |
| Designation: | Engineer |
| Experience: | 1-3 years |
| Function: | Process Management |
| Skills: | IEC 62304:2006, ISO 13485:2012, ISO 9001:2015, Project Management, Quality Management, Risk Management |
Description:
Process Management Group maintains the QMS in GlobalLogic Kharkiv, Kyiv, and Lviv; develops and maintains QMS documentation; supports delivery projects from a regulatory perspective; provides QMS training and training in regulatory requirements on request of delivery managers; implements QMS improvements; conducts internal audits; supports analysis of project issues and implementation of corrective and preventive actions; reviews project process-related documentation; monitors project and process metrics and risks; monitors applicable regulatory and statutory requirements changes.
Requirements:
- Strong knowledge of ISO 9001, ISO13485 standards (training certificates are desired)
- Ability to create and maintain QMS documentation
- Strong analytical skills
- Ability to lead internal audits, internal auditor’s certificate
- Communication skills
- Presentation skills
- Intermediate or upper-intermediate level of written and spoken English
- Knowledge of software development and project management methodologies
- Knowledge of Automotive SPICE is desired
Preferences:
CFR 21 Part 11, CFR 21 Part 820, Cause and Effect analysis, Change Management, Desarrollo De Software, Software Change Management
Job Responsibilities:
- Create and update QMS documents
- Lead internal audits, track audit follow-up activities
- Collect and analyze QMS data
- Analyze information in order to enable improvement of the QMS
- Perform the process management adviser role for the projects within the QMS: hold QMS awareness meetings, guide project managers in the project process tailoring, review internal documents, verify the results of the validation of the software used for specific needs of particular projects, review project metrics and risks, track project changes to ensure that applicable requirements are met.
- At the request of the manager, prepare materials for presentation to partners of GlobalLogic
- Validate software tools intended for QMS use
- Assist GlobalLogic consultants involved in activities within the scope of the QMS with performing quality assurance activities and ensuring compliance of products with applicable statutory requirements.
- Participate in analysis and assessment of risks for products produced on projects of the Automotive and Medical Technology Division.
- Actively participate in the improvement of the QMS.
What We Offer
Exciting Projects: Come take your place at the forefront of digital transformation! With clients across all industries and sectors, we offer an opportunity to participate in creating market-defining products using the latest technologies.
Collaborative Environment: Expand your skills by collaborating with a diverse team of highly talented people in an open, laidback environment — or even abroad in one of our global centers or client facilities!
Work-Life Balance: GlobalLogic prioritizes work-life balance, which is why we offer flexible opportunities and options.
Professional Development: Our dedicated Learning & Development team regularly organizes certification and technical / soft skill training to help you realize your professional goals.
Excellent Benefits: We provide our consultants with competitive compensation and benefits
Fun Perks: We want you to love where you work, which is why we host sports classes, cultural, social and team building activities such as sports competitions and end-of-year corporate parties. Our vibrant offices also include dedicated GL Zones and rooftop decks where you can drink coffee or tea with your colleagues over a game of table football or darts!
About GlobalLogic
GlobalLogic is a full-lifecycle product development services leader that combines chip-to-cloud software engineering expertise and vertical industry experience to help our customers design, build, and deliver their next-generation products and digital experiences. We expertly integrate design, complex engineering, and agile delivery capabilities to deliver superior business outcomes for global brands in telecom, automotive, healthcare, technology, media and entertainment, manufacturing, and semiconductor industries.
Headquartered in Silicon Valley, GlobalLogic unites over 18,000 designers and engineers across the globe. Analysts like NASSCOM and Zinnov have recognized us for being a top company in our field, and we are consistently nominated as a preferred company by both global HR consulting firms and local boards. By creating an environment that is exciting and flexible, and by fostering growth through ongoing learning and development programs, we empower our consultants to achieve both their professional and personal goals.
At GlobalLogic, we make amazing products — and careers.
