Product Test Lab, Quality Supervisor
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Job Description
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.
Leadership & People Management
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
Laboratory Operations & Oversight
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.
R&D, Design Verification & Quality Engineering Collaboration and testing support
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.
Data Integrity & Documentation
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.
QMS Compliance & Laboratory Procedures
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
Equipment & Method Lifecycle Management
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
Quality, Compliance & Audit Participation
Ensure laboratory maintains a state of audit readiness at all times
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