Lab Service Quality Engineer

Job Title

Lab Services Quality Engineer

The Lab Services Quality Engineer is responsible for ensuring quality by design, ensuring that method development and execution is always conducted in compliance with laboratory quality and compliance standards. They support technical data review and ensure data and documentation generated meet cGMP requirements. The Lab Services Quality Engineer closely collaborates with Technology Development and Operations functions and acts as the technical lead within QA department to work with engineering on review of engineering drawings, data analysis, reporting and investigations. They ensure the maintenance and enhancement of the company's Quality Management System (QMS), with a focus on continuous improvement and operational excellence.

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.

Key Responsibilities:

• Lead and execute design verification testing activities for combination products in accordance with FDA 21 CFR part 210,211, 820, ISO/IEC 17025 and ISO 13485
• Develop and review test protocols, methods, and reports to ensure compliance with design control and risk management requirements.
• Collaborate with cross-functional teams including technology development, operations and business development to support flawless project execution and delivery management.
• Ensure laboratory compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Support root cause investigations, CAPA, OOS/OOT and non-conformance resolution related to design verification testing.
• Provide technical guidance and mentorship to junior engineers and laboratory staff.
• Participate in internal and external audits, including regulatory inspections.
• Maintain and improve quality systems, including CAPA, Nonconformances, calibration and maintenance and equipment qualification.
• Stay current with evolving regulatory expectations for combination products and contribute to continuous improvement initiatives.

Data Review & Project Release

• Conduct timely reviews of project documentation including but not limited to protocol, laboratory data, audit trails, and reports prior to release to the client.

Quality Management System

• Provide problem solving and root cause analysis expertise to lead/support OOS/Deviation/CAPA investigations.
• Review Test Method Validation and provide quality expertise in the development of test methods and protocols.
• Act as technical QA representative during audits.

Compliance & Continuous Improvement

• Identify and drive implementation of improvements in current quality systems and processes.
• Achieves Key Performance Indicator (KPI) objectives by helping develop the appropriate production/quality data collection process, collecting data (including nonconformance, OOS, OOT, CAPAs, Deviations), and conducting the appropriate trending analysis to allow for the appropriate continuous improvement strategic plans to be enacted.
• Prepare and present quality reports and metrics to senior management.
• Support ZebraSci QMS integration into BD Quality Global procedures and systems.
• Train and guide staff in quality procedures and compliance.

Education and Experience

• Bachelor's or master's degree in engineering, Biomedical Sciences, or related field.
• Minimum 5 years of experience in quality engineering, preferably in a combination product or medical device environment.
• Strong knowledge of design control, risk management (ISO 14971), and verification/validation principles.
• Experience with mechanical and analytical testing of drug-device combination products.
• Familiarity with 21 CFR Part 820, 21 CFR Part 4, and ISO 13485.
• Excellent analytical, organizational, and communication skills.
• Proficiency in statistical analysis tools and quality engineering methodologies (e.g., Gage R&R, DOE, FMEA).
• Experience with Laboratory Information Management Systems (LIMS) a plus.
• Experience managing or participating in audits a plus.

Qualifications and Skills:

• Technical writing knowledge and skill. Ability to author Quality System documentation, reports including review of data and data analysis.
• Attention to details and accuracy.
• Problem Solving skills.
• Excellent organizational to manage multiple priorities and work in fast-paced, growing business environment.
• Excellent communication skills and a level of comfort to communicate internally at all levels of the organization and with customers/regulators.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

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 health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site.

Salary Range Information

$84,300.00 - $138,900.00 USD Annual

Primary Work Location: USA NJ Branchburg