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Becton Dickinson

Compare

4.0

based on 490 Reviews

Video summary

12 Becton Dickinson Jobs

Quality Engineer

BD

4.0

based on 490 Reviews

1-4 years

Bangalore / Bengaluru

1 vacancy

Quality Engineer

Becton Dickinson

posted 5mon ago

Job Role Insights

Flexible timing

Key skills for the job

Auditing Compliance Scheduling Genetics ISO Continuous Improvement

Job Description

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.

Educational Background

Bachelor s degree in Engineering or related discipline

Professional Experience

Minimum 4 years

Job Description

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
Leads continuous improvement of the QS
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

Knowledge and Skills

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
Certified as a ISO13485 Lead Auditor

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