Job Description

Summary About BD: BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. About BD TCI: BD, a 125-year-old global medical device company has started its Research and Development Organization in Bangalore India which is BD Technology Campus India (TCI). This R&D centre will be an integral part of the global R&D, in design related activities and full product life cycle management. This R&D organization will have highly skilled associates in the field of engineering and science. Position Summary: The Post Market Quality Engineering Supervisor willbe responsible for supervising the BD MMS Infusion Post Market Quality Software Engineers and Quality Engineers, and is responsible for the coordination and management of key elements of the Quality Management System (QMS), which includes CAPAs, Complaints, Change Control, Management review, QMS deviations, QMS documentation, policies, supplier quality management and GMP etc. This role is also a CAPA co-lead for PMQ and co-lead for external regulator site audits, e.g. from Regulatory Authorities (NSAI, FDA etc.) and Global Corporate Quality. Job Responsibilities: (Primary Duties, Roles, and/or Authorities) Supervisory duties for 3-5 Quality and Software personnel within the BD MMS Infusion PMQ group / function. Provide oversight and management of key elements of the Quality Management System (QMS), which includes, but not limited to: CAPAs, Internal Audit Program, Complaints, Change Control, QMS deviations, QMS documentation, policies, and GMP / Behavioral Based Quality. Provide oversight and management of the PMQ Project Management, CAPA Management and Software Validation programs provide oversight of the project schedules and collaborate with cross-functional partners to facilitate effective overall program management. Actively Leads / runs CAPA program for the department and identify areas of potential noncompliance or improvements. Provide assistance and support to the engineering and operational functions on process requirements. Responsible for ensuring adherence to internal and external regulatory requirements. Be a key member of the onsite audit team during external audits, e.g. from Regulatory Authorities and Global Corporate Quality. Assist and co-ordinate the preparation of data for Management review Meetings for all projects and CAPAs. Assist and co-ordinate implementation of global standards and corporate procedures into the site Quality Systems. To actively support the development/implementation and continuous improvement of the Quality Management Systems. To be cross trained in multiple quality systems. Develop and write SOPs, SWIs & Controlled Documents. Participate in other projects as outlined by PMQ Leadership. Compilation of monthly metrics for Plant management and Unit QA. Co-ordinate / generate quality metrics / reports for weekly meetings. Support Quality Engineering / Continuous Improvement activities as required. Ensure adherence to all BD regulatory requirements. Promotion of Quality Awareness, Culture, cGMP and BD Values within the business unit. Training of associates on Quality procedures and initiatives. Support third part Audits and Inspections. Education and Experience: Bachelor\'s degree in Engineering (any), Biomedical sciences/development, or a related field of study AND five (5) years of experience in the job offered or related occupation in which the required experience was gained. In lieu of a Bachelor\'s degree Engineering (any), Biomedical sciences/development, or a related field of study AND five (5) years of experience, the employer will also accept a Master\'s degree in Engineering (any), Biomedical sciences/development, or a related field of study AND two (2) years of experience in the job offered or related occupation in which the required experience was gained. Must have one (1) year of demonstrated experience with leadership. Must have the following: Developing software and hardware Working within a regulated environment Understanding of the risk management and quality by design processes Applying quality engineering knowledge to tasking (system design reviews and support of software beta testing) Participating in project requirement reviews Pulling reports (queries), interpreting trends and making recommendations for improvement to existing processes and tools Demonstrating intermediate knowledge of quality engineering policies, principles and best practices and Using comprehensive expertise to help improve and streamline the post market quality processes. Knowledge and Skills: Candidate shall possess strong subject matter expertise of quality engineering policies, principles and best practices previous experience in TrackWise, SAP, or Salesforce enterprise platforms is preferred. Physical Demands: Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures transcribing viewing a computer terminal extensive reading. Work Environment: Work is performed in an on-site or remote office environment and requires the ability to operate standard office equipment and keyboards. Must have the ability to walk short distances. Less than 10% travel required. This position reports within the BD MMS Infusion Post Market Quality department based in San Diego, California USA, but is located in the BD Technology Campus India (TCI). Primary Work Location IND Bangalore - Technology Campus Additional Locations Work Shift

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