Quality Systems Engineer

Job Description Summary
Performance QA activities to ensure compliance with applicable standards and medical device regulatory requirements. Contributes to the completion of specific programs and projects usually under the direction of a project leader. Excellent understanding of applicable standards and regulations and industry practices with good auditing skills. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization contacts to achieve stated objectives.

Job Description
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.

"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".

Job Responsibilities:

• Leads QS activities, including the following:
• Ensures regulatory compliance for all aspects of QS processes.
• Leads internal audit program.
• Leads preparation of Quality Management Review material, prepares and shares meeting minutes and action items. Ensure timely completion of action items.
• Leads planning and scheduling of QMS activities.
• Lead the organization in third-party quality audits, ensure availability of documentation by following war-room concept, closes the loop with external auditors on audit reports, action plan, etc.
• Authors, reviews, and provides input for QS documents to ensure compliance with QSR, ISO and EN requirements.
• Understands post-market surveillance and complaint handling process.
• Provides QS knowledge to organization as needed. Administers appropriate training, as needed.
• Reviews and improves existing quality procedure workflows and identifies areas of improvement for efficiency.
• Shall independently author concise quality investigation reports with appropriate corrective action and preventive action identified.
• Ensures document and record control per applicable standards and procedures

Education:

• Bachelor's degree in engineering or related discipline

Experience:

Minimum 4 Years Of Professional Experience
Knowledge:

• Good working knowledge and auditing experience of medical device regulations and practices (ISO13485, FDA, QSR, etc.)
• Fair understanding of QA principles, concepts, industry practices and standards. General knowledge of related technical disciplines

Skills:

• Minimum 4 years relevant experience in quality management system and GDP compliance
• Disciplined and well-organized in documentation
• Team player with excellent interpersonal and communication skills
• Proven ability to work independently with a minimum of supervisor input.
• Demonstrated ability to quickly learn new subject matter.
• Strong critical thinking
• Excellent communication and writing skills.

Additional Skills (Not essential but will be an advantage):

• Certified as a ISO13485 Lead Auditor

Trained on 21CFR 820 requirements and ISO14971.

Required Skills
Optional Skills

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift