Job Description Summary

Job Description

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 Engineer will design quality projects, develop the documentation, manage Post Market Quality CAPAs, manage local quality standards, and specify the requirements that a project or CAPA must satisfy. Quality engineers monitor the PMQ process, and are responsible for leading resolution of problems and remediation of internal and external inspection/audit observations.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Responsible for being the primary quality representative for BD MMS Infusion Post Market Quality projects – this includes optimization of post market quality processes for existing and new product development as well as sustaining efforts.
• Responsible for creation, review and/or approval of CAPA documentation in support of CAPA administration.
• Manage all post market quality aspects of the CAPA process: initiation, investigation, planning, implementation, verification of effectiveness and TrackWise administration.
• Provide clarification and guidance to teams on overall quality system with emphasis in process controls.  Report status of projects and CAPAs to designated functional leaders according to established frequencies.
• Work closely with project team members to ensure CAPA and project deliverables are met.
• Works together with other Quality Engineers to ensure effective administration of Post Market Quality projects and CAPAs.
• Monitors and ensures compliance with company policies and international standards.
• Reviews and approves Change Orders and/or Electronic Release Authorizations for new releases or design enhancements of Post Market Quality software systems.
• Identifies areas requiring quality improvement, initiates and follows through on plans of action necessary for implementation.
• Active participant in the development of project requirements, system hazard analysis and validation reviews.
• Work closely with Software Engineers to ensure effective validation of user needs.
• Ensure that CAPA and project files are complete and auditable.
• Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-functional teams.

Education and Experience:

Bachelor’s degree 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. In lieu of a Bachelor’s degree Engineering (any), Biomedical sciences/development, or a related field of study AND two (2) 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 one (1) year of experience in the job offered or related occupation in which the required experience was gained. Must have demonstrated experience with 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 intermediate knowledge of quality engineering policies, principles and best practices; previous experience in TrackWise, SAP, or Salesforce enterprise platforms is preferred.

Physical Demands: (if applicable)

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: (if applicable)

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).

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Additional Locations

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