Product Test Lab, Quality Supervisor

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.

The Laboratory Supervisor reports to the Sr. Manager within the Quality organization and is responsible for leading, supervising, and providing technical oversight of daily operations within the Product Test Laboratory (PTL). 

This role ensures laboratory activities support design verification, product lifecycle testing, and sustaining engineering efforts while maintaining compliance with applicable quality system requirements.

The Laboratory Supervisor plays a key role in cross-functional collaboration with R&D and Quality Engineering, ensuring testing strategies, execution, and documentation meet regulatory and design control requirements within a regulated medical device environment.

• Provide direct supervision, coaching, and performance management for laboratory staff

• Establish clear expectations, support development plans, and ensure appropriate training and qualification of personnel

• Foster a culture of accountability, collaboration, compliance, and continuous improvement

• Ensure effective resource planning, workload balancing, and cross-training to support business continuity

• Plan, schedule, and prioritize laboratory testing activities aligned with project timelines and organizational priorities

• Ensure laboratory operations are executed efficiently, consistently, and in compliance with established procedures

• Maintain oversight of laboratory inventory, equipment, consumables, and test samples

• Drive continuous improvement initiatives to enhance laboratory efficiency, throughput, and data quality.

• Partner closely with R&D and Quality Engineering to support design verification (DV), validation, and characterization testing activities as such as

Collaborate on development and refinement of:

o    Test strategies and Scheduling

o    Verification protocols review

• Ensure alignment of test execution with requestors

• Support protocol reviews with Quality Engineering, ensuring compliance, clarity, and completeness prior to execution

• May participate in cross-functional design reviews and provide feedback on test feasibility, risks, and data interpretation

• Support investigation of test failures, working collaboratively with R&D and Quality to drive root cause analysis and resolution.

• Ensure accurate, timely, and compliant test data collection, review, and documentation within controlled systems (e.g., QMS, SAP)

• Review raw data, test results, and reports for compliance and technical accuracy

• Ensure all testing is executed per approved protocols and controlled procedures

• Validate laboratory spreadsheets, automated tools, and data acquisition systems used for analysis as applicable.

Ensure laboratory operations are compliant with Quality Management System (QMS) requirements, including:

o    Controlled procedures and work instructions

o    Document control and record retention

o    Change management processes

• Develop, maintain, and continuously improve laboratory procedures, test methods, and standardized work instructions

• Oversee equipment lifecycle, including IQ/OQ/PQ (IOPQ), calibration, preventive maintenance, and troubleshooting

• Generate and approve qualification protocols and reports for laboratory and software-based systems

• Support method development, validation, verification, and transfer activities

• Ensure equipment and methods remain in a validated/qualified state

• Ensure laboratory maintains a state of audit readiness at all times

• Actively participate in internal, external, and regulatory audits and inspections, representing laboratory operations

• Support audit preparation activities, including documentation review and gap assessments

• Address audit observations through CAPA development and implementation

• Participate in nonconformance investigations, deviations, and risk assessments related to laboratory activities

• Bachelor’s degree in Biology, Microbiology, or other related Life Science

• A minimum of 5 years' proven experience, with a minimum of 2-3 years working in a laboratory in a team lead position preferred

• Good verbal and written communication skills

• Team-oriented