Lead Quality Engineer

Summary
As directed by the Quality Manager, the Lead 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.
Works under general direction while independently determining and developing approaches to
solutions. Frequent inter-organization contacts to achieve stated objectives.

Primary Responsibilities

• Support design control projects.
• Writes and leads risk management activities.
• Support the efforts in creation of specifications, design, and test methods for the new products.
• Translate customer needs into engineering requirements into specific product, packaging
  

and process specifications.

• Write detailed technical reports based on design verification analysis/testing for design
  

changes and product design activities

• Interface with manufacturing on an ongoing basis during the development stages to ensure
  

manufacturability of the design solutions.

• Consistent application of technical principles, theories, concepts, and quality sciences /
  

tools.

• Proven problem-solving skills
• 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
  

efficiency of the established Quality System and Good manufacturing Practices.

• Support the implementation of new products, processes, and changes by developing
  

quality plans, approval of validation plans and protocols, inspection methods, work
instructions, and raw material specifications and inspection plans.

• Support manufacturing and quality process improvement projects as an effective team
  

member or leader using Continuous Improvement and Six Sigma tools.

• Analyse and interpret inspection and process data to identify and prevent quality problems
  

and continuous improvement opportunities.

• Responsible for the investigation, documentation, root cause, and corrective action
  

activities of deviations and non-conforming material.

• Responsible for the investigation, documentation, root cause, and corrective action
  

activities of customer complaints.

• Conduct Internal and Supplier Audits. Provide audit support for customer and regulatory
  

audits (preparation, closure, etc.)

• Provides training for operations and engineering teams or best practices.
• Communicates across functions / departments for assigned areas of responsibility.
• Comply with all local, state, federal, and BD Safety regulations, policies, and procedures
  

including RCRA Hazardous waste regulations
Required Skills
Optional Skills
Primary Work Location
IND Bengaluru - Technology Campus
Additional Locations
Work Shift