Become A Senior Quality Specialists

* Ensure favorable compliance profile through site
* audit readiness, maintenance and management of internal/external audit program
* in accordance with J&J Quality Standards, Policies and Regulations.
* Ensure Quality activities are operating in a
* state of compliance and continuously upgraded to meet business needs.
* Participate and support internal and external
* regulatory compliance audits.
* Review and recommend product disposition
* decisions.
* Author, review, or approve operating procedures
* manufacturing protocols, risk assessments, or other documentation as needed.
* Problem Solving- ability to resolve issues from
* a Quality perspective.
* Influence consistent compliance culture behaviors
* across the organization.
* Ensure strong compliance is maintained across
* all elements of daily manufacturing operations and all existing Standard
* Operating Procedures (SOP) are being followed through active presence on the
* shop floor.
* Analyze data in the scope of its own roles and
* responsibilities to identify, monitor, and control trends associated with
* manufactured product, quality systems, manufacturing processes, and compliance
* audits and recommend mitigating actions.
* Conduct and/or support internal compliance
* audits and author or review compliance audit reports.
* Author, review, provide guidance, and approve
* supporting documentation for NC (All levels), CAPA, and change control
* processes.
* Use Process Excellence tools in INV and CAPA
* root cause investigations and determination of appropriate corrective and
* preventative actions.
* Author, review, and provide guidance on the use
* and development of operating procedures.
* Execute product release or master data
* transactions within SA
* Provide plant wide training and guidance on
* Quality and Compliance topics.
* Review and provide guidance on validation
* documentation and processes

* Lead cross functional teams to facilitate the development, review and approval of global Field Corrective Action (FCA) Plans.
* Define recall strategy and actions that are compliant with all applicable regulations and internal procedures to properly address a product quality issue.
* Facilitate the development of FCA materials (letters, presentations, etc…) to effectively communicate relevant information to appropriate customers (e.g. health care providers, risk managers, hospital personnel, patients) and Medtronic field personnel to mitigate patient risks.
* Work with regulatory contacts to identify, plan and coordinate notifications to regulatory bodies and respond to regulatory and field inquiries in a timely fashion.
* Oversee the global execution of the global FCA plan to ensure adherence to plan actions and milestones.
* Assist in the response to regulatory inquiries related to Field Corrective Actions
* Maintain data and prepare reports, presentations, proposals and status updates for management.
* Performs other duties as assigned.
* Travel up to 10% of the time (domestic and international travel

* Actively participate in SQA processes that will validate all software development efforts
* Perform functional, regression and end-to-end testing, including both back-end and front-end testing of entire system, subsystems and interfaces to other systems
* Write UI automation code using frameworks like Selenium
* Perform API testing and automation
* Understand advance database concepts and apply to testing
* Collaborate with the operations and development staff on integrating the test infrastructure into the build and deployment infrastructure
* Work closely with local and global [India/China/Germany] software development and QA teams
* Maintain test data, test cases and support Jira bug tracking
* Guide and mentor junior SQA team members
* Help QA Manager in creating, architecting, managing and evangelizing the existing software quality team’s processes to higher standards

* Execute projects utilizing Agile/Scrum Methodology.
* Perform the planning of quality assurance activities needed in projects including effort estimation, timing and resources.
* Track and ensure delivery of customer requirements using, among others, requirement traceability matrixes.
* Coordinate the preparation and the execution of tests and perform the test monitoring and reporting, using tools like GTP and CSN.
* Prepare and moderate reviews (specification, design, code etc.) and perform the follow up tracking of the review results.
* Perform formal checks and usability checks of deliverables to the customer before the handover to the customer.
* Participate in functional test execution, including executing automated testing strategies.
* Communicate with the customer concerning QM topics in alignment with the project manager/architect.
* Moderate lessons learned sessions and root cause analysis.
* Perform QM monitoring and QM status reporting and proposes corrective actions.
* Pro-actively provide feedback regarding methodology, tools and best practices in order to constantly improve the development methodology and tools.
* Actively contribute to QM community by sharing experiences and ideas for QM excellence.
* Participate in SAP Innovative Business Solutions initiatives focused on continuous improvement and operational excellence