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Project Leader 2

Bengaluru, Karnataka
Posted: 12 February, 2019

Job Descriptoin

Role Summary:
The Change Control Board Leader owns the change control management of diagnostic cardiology products and drives timely closure of the various change requests. This role requires interaction with Product Management, Engineering, Sourcing, Manufacturing, Quality, Service and other GEHC design functions to review the entire change control process, deliver the on-going product performance and clinical quality expected by global customers.

Essential Responsibilities:
Specific responsibilities include (but are not limited to):
  • Ability to own and drive the change control management including reviews and timely closure of various change requests in a compliant manner.
  • Review and control the releases namely ER’s, MR’s and ECO’s
  • Conducting reviews to process the Supplier & Engineering change requests & routing the review output for approvals.
  • SPOC for the modality SCR’s and ensure all these are addressed on time.
  • Verify and validate the engineering change implementations including process, documentation, following appropriate approval matrix and ensure all the QMS goals are met.
  • In addition to change responsibilities, drive the EOPL (End of product life) programs for Diagnostic Cardiology products.
  • Support all the QMS relevant audits.

Quality Specific Goals:
1) Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2) Complete all planned Quality & Compliance training within the defined deadlines
3) Identify and report any quality or compliance concerns and take immediate corrective action as required
4) Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program deliverable
5) Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible

Qualifications/Requirements:
1) BE/B Tech degree in Mechanical / Electrical / Electronic Engineering, Biomedical Engineering, or equivalent
2) 4 years of relevant product change control management experience and an additional 4-5 years of combined new product design / design change and change control management experience
3) Demonstrated ability to work as part of a cross-functional and global project team
4) Strong, demonstrated oral and written communication skills
5) Demonstrated project planning ability
6) Demonstrated experience bringing original design from concept to product release.

Desired Characteristics:
1) MS Degree in Mechanical / Electrical Engineering, Biomedical Engineering or equivalent experience
2) Change Control Management experience
3) Medical device design and support experience
4) Working knowledge of ISO, FDA and other applicable medical device regulatory standards
5) Familiarity with GEHC products
6) Demonstrated success leading global technical project teams

About Us:
GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com

Locations: India; Bengaluru

GE will only employ those who are legally authorized to work in the United States for this opening.


GE Careers - 30+ days ago

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