Job DescriptionJob Description number: TCI-JD025Reporting To: Staff Quality Engineer / Quality ManagerPosition Title: Senior Quality EngineerJob Group: JG3Department /Segment: Quality Engineering / BD MedicalLocation: Bengaluru, India
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. Thecompany develops innovative technology, services and solutions that help advance both clinicaltherapy for patients and clinical process for health care providers. BD has 70,000 employeesand a presence in virtually every country around the world to address some of the mostchallenging global health issues.
BD, a 125-year-old global medical device company has started its Enterprise Center in
Bangalore, India called BD Technology Campus India (TCI). This Enterprise Center will be anintegral part of the global network for BDX. It will have presence of R&D, Quality, Regulatory,IT and other functions. The center boasts of some of the brightest minds who work in a uniqueenvironment that fosters and supports ingenuity. BD TCI is dedicated to serving BD's customersand patients thereby contributing its bit towards advancing the world of health.
Performs a variety of quality assurance activities to ensure successful completion of projects
or aspects of large programs. Applies technical expertise and knowledge of advanced statisticaltechniques to support engineering work in the design, development, and evaluation of medicaldevices. Supports development and successful implementation of quality systems andprocedures. Supports maintenance and expansion of QMS as required. Frequent interorganizationalcontacts on technical matters often requiring coordination between organizations.
Bachelor's degree in mechanical engineering, biomedical engineering, or related engineering
discipline.
4-9 years of relevant experience
? Leads or assists in the development of, and continuous improvement of, quality systemsfor R&D in compliance with 21 CFR 820, ISO 13485 and EN requirements with specificfocus on design control.? Ensures compliance with BD quality policies, procedures, and practices throughappropriate communication, training, and education of sound quality assurance principles.? Contributes as a team member on development projects carrying out assigned qualityassurance responsibilities in a timely, diligent, and professional manner.? Promotes advanced understanding of customer needs and processes to ensure relevant and innovative product development.? Applies Design to Cost and Design for Manufacturability methods to support project leader in achievement of project objectives.? Supports cross-functional planning, coordination, and reviews.? Leads Risk Management plans/ reports and situational analyses for products under design authority.? Promotes the use of statistics in the testing and control of quality. Applies Six Sigma methodology to support product development process.? Actively mentors associate in related technical roles. Provide technical direction and frequent feedback. Participate and assist in their success.? Contributes to assembly and maintenance the Design History File (DHF).? Supports quality initiatives for plant issues.
- Knowledge and Skills:
- Knowledge
? Advanced understanding of design control, disciplined product development
processes, regulatory, and quality requirements.? Good working knowledge of medical device regulations and practices (ISO13485, 21 CFR 820, etc.).? Complete understanding of quality assurance principles and concepts, totalquality tools, continual improvement approaches, industry practices, andstandards.? Advanced knowledge of Six Sigma methodology, statistical methods andanalysis.? Ability to translate customer needs into design inputs and specifications.? Good knowledge and understanding of process development, total qualitytools, and continual improvement approaches
? Excellent Project Management and technical writing skills.
? Strong critical thinking, analytical, and problem-solving skills.? Ability to prioritize and multi-task many different forms of work input that areboth strategic and operational in nature.
- Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)
? Master's degree in related engineering discipline.? Certified Quality Engineer (CQE) and/or Six Sigma Green/ Black Belt.? Knowledge of engineering performance enhancement tools in the area of Design for SixSigma (such as Voice of the Customer, Statistics, Design of Experiments, and ProblemSolving).
Required Skills
Optional SkillsPrimary Work LocationIND Bengaluru - Technology CampusAdditional LocationsWork Shift
