Hi
This is Aravinnd, - Recruitment Team from MSR Cosmos
We have an urgent requirement as follows:
Please respond with resumes in MS-Word Format with the following details to aravind@msrcosmos.com
Full Name :
Location :
Relocation :
Contact Number :
Email :
Skype Id :
Last 4 digit SSNO :
Availability for project :
Availability for Interviews :
Visa Status and Validity :
D O B :
Years of Exp :
Requirement Details
Sr. IT Business Analyst
Location:
Alameda, CA, USA ( Onsite can start in a month or 2 months )
Experience:
8 to 15 Years
Skills Required:
FDA/regulatory Reporting processes, quality, medical device
Job Description:
Sr. IT Business Relationship Manager will be responsible for working closely with Quality and Regulatory business partners to develop and maintain comprehensive Quality and Regulatory IT road maps for Complaints Systems. Responsible for IT Capital and Expense financial projections, planning, and oversight for Quality and Regulatory systems. Responsible for identifying technology solutions to meet evolving Quality and Regulatory business needs. Eliminate redundant systems and manual operations, while implementing consistent and automated best practices. This role is also responsible for compliance with applicable Corporate and Divisional Policies and procedures. Consulting toward business process owners on tools and solutions based on own area of IT expertise. Closely collaborate with other disciplines like corporate IT, Engineering, and business process owners in the BU. Influence and partner with business leaders (Manager, Director) to manage and align the process specific IT portfolio.
• Provide expert oversight of global medical device quality and regulatory systems and roadmaps
• Provide expertise in the design, development, deployment, and maintenance of quality and validated systems
• Ensure data integrity of FDA Reporting processes
• Liaise with IT, operations, and quality and regulatory business functions.
• Responsible for compliance with applicable Corporate and Divisional policies and procedures. Operates with broad goals and objectives. Has direct impact on capital budget, expenses and project completion.
• Ensure compliance (Complaint Handling, Regulatory Reporting, eMDR, change control, etc), improve quality, and reduce costs by optimizing and integrating quality processes, including management and reporting.
• Facilitate conversations with stakeholders in order to help understand, document, and solve business needs
• Understand, document and explain issues and requirements from both a technical and business point of view
• Collaborate with design and development teams to document business requirements, product plans, workflows, risks, and estimates in shared services/managed services setup
• Analyze multifaceted business problems and issues using data from internal and external sources to provide insight to decision makers.
• Conduct analysis using standard practices and tools associated with data gathering and analysis.
• Resolve system defects ensuring acceptable system testing and timely deployments in collaboration with IT and external vendor to help operations conduct business more effectively.
• Establish and maintain communication channels with process owners, key team members and internal stakeholders to support data gathering and analysis.
• Assist with querying data for extraction, building or modifying smart lists and transitioning ad hoc report requirements.
• Maintain system protocols by ensuring business owners are updating policies and procedures in accordance with QMS policies.
• Provide user training and process hand-off for newly released functionality and enhancements.
Location:
Alameda, CA, USA ( Onsite can start in a month )
Experience:
8 to 15 Years
Skills Required:
FDA/regulatory Reporting processes, quality, medical device
Roles:
• Understand people, process and technologies required for Design Controls, Post Market Surveillance, Management Controls, Process Controls and complaint management processes
• Building and maintaining expertise on the IT portfolio for client. Proactively analyzes business processes; elicits, analyzes, and documents business requirements; identifies alternative solutions, assesses feasibility and makes recommendations typically seeking to exploit and leverage new or existing IT technology components
• Champion change and innovation. Stimulates creativity, innovation and open to new ideas.
• Constant awareness of corporate IT standards, technology trends, evolving regulatory requirements and their applicability to the business process and IT portfolio, and influences the IT stakeholders and partners in addressing these evolutions in the most efficient way.
• Manages collaboration and partnership with Corporate IT Services including Plan/Build/Run teams.
Minimum Education & Qualification
• Bachelor's degree in Engineering or related field
• 8+ years of Quality Systems Expertise
Stay Safe
Thanks & Regards,
Aravinnd
MSR COSMOS
6200 Stoneridge Mall Rd, Ste 300, Pleasanton, CA - 94588
Desk : 925 399 7145
Textnow : 732 574 5974
Fax : 925-219-0934
Email : aravind@msrcosmos.com
URL: http://www.msrcosmos.com
- Microsoft Gold Partner
- SAP Silver Partner
- Oracle Gold Partner
- Hortonworks Silver Partner
- Cloudera Silver Partner
- E-Verified
- WBE Certified
Note: This email is not intended to be a solicitation. Please accept our apologies and reply in the subject heading with REMOVE to be removed from our Mailing list.
Any information and documentations including Govt issued ID or government issued documents if forged, manipulated or Falsified is considered as a felony as per US laws Such actions are a punishable offense and can lead to Criminal Investigation or Indictment
Confidentiality Notice:
Unless otherwise indicated, email transmission is not a secure form of communication and your reply may not be encrypted. The information contained in this message is proprietary and/or confidential. If you are not the intended recipient, please: (i) delete the message and all copies; (ii) do not disclose, distribute or use the message in any manner; and (iii) notify the sender immediately.
You received this message because you are subscribed to the Google Groups "Xrecnet IT Recruiters Network - Corp to Corp IT Jobs & Hotlists" group.
To unsubscribe from this group and stop receiving emails from it, send an email to xrecnet+unsubscribe@googlegroups.com.
To view this discussion on the web visit https://groups.google.com/d/msgid/xrecnet/CAMSx0H2SpYuVGoOH%3DoPbpLFooij1xscyqijiYy0ct8rKrCSSzw%40mail.gmail.com.
No comments:
Post a Comment