Job Description Summary

Job Description

We are the makers of possible 

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. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

The Sr. Quality Engineer will serve as the Core Team quality lead within a cross-functional team to product development and manufacturing to improve product quality, compliance, reliability, and process capability on the BD Pyxis MedBank portfolio of medical and non-medical devices.

This position will facilitate teams in identifying, documenting, assessing, correcting, and preventing quality issues using risk analysis and root cause analysis tools. Additional responsibilities will include quality planning and establishing and maintaining metrics to improve quality system processes, process capability, reliability, compliance, and quality of products.

Accountabilities:

• Develop and implement reliability analysis, design, validation, and assessment methods to support successful new product introductions and/or sustaining product changes.

• Provide quality leadership to new product development and sustaining product teams in the areas of design control: design and development planning, design input, design outputs, design review, design verification and validation, design transfer, design change, process validation, risk management, and requirement & specification development.

• Support product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders.

• Support detailed Risk Assessments, updates to System Hazard Analysis, and present analysis to the Risk Management Board.

• Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering, and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs strategies and requirements. Ensure product development and validation programs meet requirements of FDA, ISO, local and international regulations when applicable.

• Work with Engineering and R&D to develop reliability testing strategy plus modeling methods specific to products and systems for HALT, Shock and Vibration, MTBF and others as required.

• Manage and assess reliability risks that could adversely affect operations by providing analysis, diagnostics, and reporting. This will involve data analysis techniques to help companies meet accepted reliability standards.

• Lead and assure appropriate activities to address product or process non-conformances through the CAPA process.

• Support situation analysis and field actions when circumstances including product containment arise.

• Trend, analyze, and report on quality data (e.g., post market surveillance, operations metrics) to improve product and process; develop recommendations based on data analysis.

• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.

• Drive continuous improvement to BD’s QMS processes and procedures.

Qualifications:

• Bachelor’s degree in Engineering or Life Sciences

• Minimum 7 years of related experience in design and development in a regulated environment, minimum of 3 years of experience within medical device industry

• Experience supporting and/or leading CAPA and remediation activities.

• Hardware experience is preferred.

• Quality Certification preferred (e.g., CQE).

• Knowledge of medical device regulations (FDA 21CFR80.820, ISO13485, ISO14971).

• Results orientation with strong written and oral communications skills to lead cross-functional teams.

• Ability to effectively lead and influence cross functional teams.

• Strong problem identification and problem-solving abilities.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial stat