Lead Quality Engineer

BD; Bengaluru; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

BD Bengaluru – Technology Campus is seeking a seasoned Quality Engineer to support design control projects, lead risk management activities, and translate customer needs into engineering specifications for new products. You will collaborate with manufacturing to ensure manufacturability and apply Six Sigma tools for process improvements.

The role requires a strong background in medical device quality systems, ISO 13485, ISO 14971, and regulatory requirements, with a focus on robust documentation

Qualifications

• Bachelor’s degree in Engineering or related discipline.
• A minimum of 8 years meaningful experience or a combination of equivalent education and proven experience.
• Good working knowledge of medical device regulations (ISO13485, ISO 14971, FDA 21CFR820).

Responsibilities

• Support design control projects.
• Write and lead risk management activities.
• Support creation of specifications, design, and test methods for new products.
• Translate customer needs into engineering requirements and product specifications.
• Write technical reports based on design verification analyses and tests.
• Interface with manufacturing to ensure manufacturability of design solutions.
• Apply quality principles and Six Sigma tools for process improvements.
• Investigate deviations, root cause analysis, and corrective actions.
• Assist with supplier and internal quality audits.

Skills

Disciplined documentation

Team player

Independent worker

Education

Bachelor’s degree in Engineering or related discipline

Job description

We Are The People Who Give Possibilities Purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Educational Background

Bachelor’s degree in Engineering or related discipline.

Professional Experience

A minimum of 8 years meaningful experience or a combination of equivalent education and proven experience.

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.

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
• 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) (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

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

Note: This position is Approved by BU and Quality Leadership.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift