Lab Service Quality Engineer

BD

143d • $84,300 - $138,900

About The Position

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. S(he) supports technical data review and ensures 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. S(he) ensures the maintenance and enhancement of the company’s Quality Management System (QMS), with a focus on continuous improvement and operational excellence.

Requirements

• 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.

Nice To Haves

• 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 skills 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.

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.
• Conduct timely reviews of project documentation including but not limited to protocol, laboratory data, audit trails, and reports prior to release to the client.
• 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.
• Identify and drive implementation of improvements in current quality systems and processes.
• Achieve Key Performance Indicator (KPI) objectives by helping develop the appropriate production/quality data collection process, collecting data, and conducting the appropriate trending analysis.
• 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.

Benefits

• Competitive salary range of $84,300.00 - $138,900.00 USD Annual.
• Opportunities for professional development and growth.
• Supportive work environment that values contributions and opinions.
• Commitment to employee well-being and development.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree