Lead Quality Engineer
- Bangalore, Karnataka
- Permanent
- Full-time
Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization contacts to achieve stated objectives.Job DescriptionPrimary 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
- 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).
- 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