| Fully Remote !! ALM Admin !! No H1b at Remote, Remote, USA |
| Email: [email protected] |
| From: Shubham Jaiswal, KPG99,INC [email protected] Reply to: [email protected] ALM Admin NO H1(must share visa copy both sides) Previous life sciences exp. is definitely required Rate: $60/hr. on C2C Client : Insulet Corporation Visa : No H1b But Candidate must share visa copy both sides. Responsibilities Administer and maintain ALM systems (i.e. Helix/Siemens Polarion) necessary for best in class implementation of design elements including but not limited to: design requirements, risk management artifacts, verification testing/reporting, tracing and product issue tracking. Lead/coordinate data migration between ALM tools working with SMEs ensuring minimal impacts to existing data configurations. Ensure proper configuration for efficient and clear traceability among design input, design output, verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file. Provide access and training to new ALM users and Managers on usage of ALM modules. Responsible for standardizing, implementing, and maintaining, template's within ALM tools. Drive integration of external tools with ALM ensuring proper synchronization and mapping. Create and release procedures defining general navigation/use and specific customizations/integrations required when optimizing tool capabilities Develop metrics, dashboards and reports across different functions providing meaningful operational/performance metrics and status. Collaborate with IT as needed ensuring statements of work, purchase orders, and invoices are current with ALM vendors/partners. Represent R&D as the liaison for existing PLM tools (i.e. Arena) as required Perform other general administration duties as required. Education and Experience/Minimum Requirements B.S. in Engineering or technical discipline 8+ years of experience working with R&D ALM systems, implementing, and customizing complex workflows, data migration, account permissions and training modules. Excellent management skills: experience and capability managing collaboration under a Quality Management System (QMS), as part of a cross-functional team that includes development/verification/validation/procurement/manufacturing/regulatory and quality experts. Demonstrated expertise in product development and commercialization activities related to Design Controls utilizing ALM or PLM tool. Demonstrated examples of collaboration skills, effectively working in a team environment Experience managing inputs from several sources, self-organized, cross-functional project teams in a matrixed environment Preferred Skills and Competencies: Two (2) years of higher education Five (5) years of experience working in a regulated medical device (Class 1, 2 or 3) industry using design and development processes in compliance with FDA 21 CFR part 820, ISO 13485, IEC 62304, or ISO 14971. Experience with integration of external tools into ALM system. Demonstrated experience with Confluence administration and customizing spaces. Ability to construct custom dashboards and reporting metrics from ALM tools. Team player with ability to mentor team members. Thanks and Regards, Shubham Jaiswal | Sr. Technical Recruiter | KPG99,INC | MBE Certified Firm Direct: 609-722-8051 | [email protected] | www.kpgtech.com 3240 E State St EXT , Hamilton, NJ 08619 Linkedln : https://www.linkedin.com/in/shubham-jaiswal-b1b02a20b Note: KPG99 does not endorse undesired email. If you do not want to receive our mails, please reply with Remove in the subject; I would ensure that you are not troubled further. I apologize for any inconvenience Keywords: rlang information technology New Jersey |
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| Thu Sep 21 20:17:00 UTC 2023 |