Product Test Lab, Quality Supervisor

Becton Dickinson Medical Devices•San Diego, CA

3d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Biology, Microbiology, or other related Life Science
A minimum of 5 years' proven experience
A minimum of 2-3 years working in a laboratory in a team lead position preferred
Good verbal and written communication skills
Team-oriented

Responsibilities

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
Collaborate on development and refinement of test strategies and scheduling
Collaborate on review of verification protocols
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 controlled procedures and work instructions, document control and record retention, and 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