Job Description Summary

The Sr. Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.

Job Description

Consistent application of technical principles, theories, concepts and quality sciences / tools. Proven problem solving skills. Makes measurable improvements to BD processes and procedures. Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements. Is a team member representing Quality on new product development and sustaining engineering projects. Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc. Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good manufacturing Practices (Auditor-in-Training). Authors Post-Market Surveillance Reports and supports Post-Market Surveillance activities May perform other duties as required

Education and Experience:

Typically requires a minimum of a bachelor’s degree in science, engineering, or other relevant discipline

and a minimum of 5 years relevant experience or a combination of equivalent education and relevant

experience.

Knowledge and Skills:

• Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products.
• Applied knowledge of Corporate and/or Unit requirement.
• Able to contribute to the completion of specific programs and projects.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.
• Able to revise policies and procedures
• Able to make presentations
• Can independently determine and develop approach to solutions.
• Able to provide guidance and work direction to lower level project developers.
• Can design and perform development working independently within defined parameters with minimal supervision required.
• Experience with BD software systems utilized in the Quality Systems is desirable.
• Must have knowledge/specialization in one or more of the following areas:

• Acceptance sampling theory and application
• Statistical process control methods and application
• Measurement system/test method knowledge and analysis
• Quality planning
• Failure analysis investigation
• Design of Experiments
• Process mapping and value stream analysis
• Hypothesis testing
• Descriptive statistics
• Process capability analysis
• Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc.
• Risk Management
• Supplier quality management
• Auditing
• Design/development tools
• Process validation
• Software validation

Physical Demands: (if applicable)

N/A

Work Environment: (if applicable)

N/A

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift