Quality Enginner

Job Description number: TCI-JD026

Reporting To: Staff Quality Engineer / Quality Manager

Position Title: Quality Engineer

Job Group: JG3

Department / Segment: Quality Engineering / BD Medical

Location: Bengaluru, India

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 Enterprise Center in Bangalore, India called BD Technology Campus India (TCI). This Enterprise Center will be an integral 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 unique environment that fosters and supports ingenuity. BD TCI is dedicated to serving BD's customers and patients thereby contributing its bit towards "advancing the world of health".

Position Summary

Performs quality assurance activities to ensure compliance with applicable medical device regulatory requirements.Contributes to the completion of specific programs and projects usually under the direction of a project leader.Good understanding and frequent application of quality assurance principles, design control concepts, industry practices, and standards.Works under general direction while independently determining and developing approaches to solutions.Frequent inter-organization and limited outside customer contacts.

Educational Background

Bachelor's degree in mechanical engineering, biomedical engineering or related engineering discipline.

Professional Experience

0-5 years of relevant experience

Job Responsibilities

•       Participates in design control activities of medical device products. Ensures proper design and development control and its documentation as per ISO 13485/ FDA QSR Quality System. 
•       Leads or supports Risk Management in accordance with ISO14971. 
•       Contributes as a team member on development projects carrying out assigned quality assurance responsibilities in a timely, diligent, and professional manner.
•       Creates, implements changes to, and maintains controlled documents as needed (e.g., SOPs, Specifications, Methods, etc.) to ensure strict compliance of R&D functional operation with ISO 13485/ 21 CFR 820 Quality System/ EN requirements.
•       Supports continuous improvement of the Quality Systems.
•       Applies Statistical tools to support product development process.
•       Provides QS knowledge to organization as needed.  Administers appropriate training as needed.
•       Participates in the ongoing operations of QA/QS activities.

Knowledge and Skills

Knowledge

Good working knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.).

Practical and demonstrated experience of Quality or Reliability engineering, risk analysis, product development and verification/validation testing in the medical device industry.

Demonstrated hands-on experience with Design Control procedures.

Experience in a Phase-Gate development process.

Experience in directly applying statistical methods for quality improvement.

Good knowledge and understanding of process development, total quality tools, and continual improvement approaches.

Skills

• Good technical writing skills.
• Familiarity with statistical methods and analysis and/or Minitab software. 
• Team player with excellent interpersonal and communication skills.

Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)

•      Familiarity with Six Sigma methodology. 
•      Experience in high volume manufacturing and assembly processes, particularly those of plastic injection molded parts and assemblies.
•      Disciplined and well-organized in documentation (plans, requirements, drawings, design reviews, and test methods).
•      Strong critical thinking, analytical, and problem-solving skills.

Any additional Information (Specially if needed for Quality or legal purposes)

• Certified Quality Engineer (CQE)
• Certified Six Sigma Green Belt (SSGB) and/ or Six Sigma Black Belt (SSBB)

Required Skills

Optional Skills

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