Job Description 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.

Job Description

Primary Responsibilities

• Support design control projects.
• Experience in Sterilization processes
• 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.
• Analyze 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

Knowledge and Skills

Knowledge

• Good working knowledge and auditing experience of medical device regulations and practices (ISO13485, ISO 14971, FDA, 21CFR820 Quality System Regulation, etc.)
• Fair understanding of QA principles, concepts, industry practices, and standards. General knowledge of related technical disciplines.
• Extensive knowledge in Design Control principles
• Experience in Risk management activities
• Experience in Sterilization Processes
• Proven understanding of statistical concepts such as in measurement system analysis, Gage R&R, and validation
• Applied knowledge of applicable regulatory, Corporate and / or Unit requirements.
• Experience in design of experiments and statistics
• Class II / III medical device experience
• Knowledge of six sigma methodology (preferred)
• ASQ certified quality engineer (CQE) or certified quality auditor (CQA) (preferred).

  Skills

• 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

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

• Demonstrated ability to quickly learn new subject matter
• Strong critical thinking
• Excellent communication and writing skills

Required Skills

Optional Skills

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Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift