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CCB Leader

Bengaluru, KA
Job Code:
  • Manufacturing & Production
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Job Details

The Change Control Board Leader owns the change control management of diagnostic cardiology products and drives on 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 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 ERs, MR s and ECOs 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 electrical test and verification activities related to diagnostic cardiology products. Support all the QMS relevant audits.Quality Specific GoalsAware 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/positionComplete all planned Quality & Compliance training within the defined deadlinesIdentify and report any quality or compliance concerns and take immediate corrective action as requiredSupport compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program DeliverablesParticipate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible 4 years of relevant product change control management experience or 8 years combined new product design and change control management experienceDemonstrated ability to work as part of a cross-functional and global project teamStrong, demonstrated oral and written communication skillsDemonstrated project planning abilityDemonstrated experience bringing original design from concept to product release.Desired CharacteristicsMS Degree in Electrical Engineering, Biomedical Engineering or equivalent experienceStrong written and verbal communication skillsDemonstrated success with conflict resolutionChange Control Management experienceMedical device design and support experienceExpertise with Electrical Design, single board computer and embedded device design and supportWorking knowledge of ISO, FDA and other applicable medical device regulatory standardsFamiliarity with GEHC productsDemonstrated success leading global technical project teams
Additional Degree: BE/ B.Tech (Engineering)

Experience: 4-8


Design | Electrical/Electronic
Applying for this job will take you to an external site


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