Jobs with Chander Dhall, Inc.

Software Program Manager

PALO ALTO,CA


Job Description/Requirements

 

The Program Manager will be instrumental in dictating the software documentation and development process, ensuring that it adheres to company-defined standards. You will act as the liaison between the Product Management, Software, Quality Assurance, and Regulatory Teams. We are seeking individuals who are ready for a challenge and are driven to meet the needs of our patients and growing business.
RESPONSIBILITIES
  • Manage high-level documentation processes and drive teams to follow such processes.
  • Administer design control software utilized in the documentation and development process.
  • Review and approve software system validations and changes.
  • Assist in the creation and review of content such as requirements documents, test plans, risk assessments, hazard analyses, etc.
  • Generate, review and/or maintain records or documents in a detailed and consistent manner.
  • Participate in the planning, execution and follow up on internal and external quality audits.
  • Ensure compliance with applicable State and Federal regulations and Company Policies, Procedures, Goals and Objectives.
  • Train various team members on internal Quality Management policies.
  • Coordinate and manage continuous improvement projects.
  • Own deviation and change control records.
REQUIREMENTS
  • Bachelor's Degree from a top-tier university.
  • 5+ years of professional work experience in software product/program management, compliance management, or information technology.
  • Experience with validation of software/IT systems in a regulated industry such as medical devices or financial services.
  • Working knowledge of the development of protocols for the validation of complex computer systems.
  • Knowledge of all phases of the product development life cycle including design, implementation, debugging, verification, qualification, and production support.
  • Strong presentation and communication skills required.
  • Experience with Quality Systems Standards (ISO13485, FDA CFR 21 Part 820 and Part 11) highly desired.
  • Experience with software verification and validation of medical device software desired.
  • Experience with Laboratory Automation Systems (LIMS/LIS) a plus.
  • Demonstrated high level of initiative and ability to function superbly in both individual and team environments.
  • Ability to work in a complex and fast moving environment and handle stressful situations and deadline pressures well.
  • Some travel may be required.
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