Quality Supervisor

Position Summary

The Quality Supervisor is responsible for leading quality operations within an ISO 13485–certified optical manufacturing laboratory. This role has initial responsibility to support the development and buildout, and the responsibility of ongoing management of the QA Testing Lab.

In addition to oversight of the non‑conformance/breakage, execution of product and process quality audits, and overall quality compliance.

This position plays a critical role in establishing scalable, compliant testing capabilities that ensure optical products meet safety, performance, and regulatory requirements. The Quality Supervisor provides hands‑on leadership, builds quality infrastructure, and partners cross‑functionally to drive operational excellence and continuous improvement.

• Support the initial buildout of the QA Testing Lab, including equipment layout and installation.
• Develop, implement, and validate test methods and inspection processes for optical products, including (as applicable):
• Optical performance (Rx accuracy, power verification, prism, axis)
• Coating performance (adhesion, abrasion resistance, durability)
• Surface quality (cosmetics, defects, haze)
• Establish and maintain documented procedures, work instructions, and acceptance criteria in compliance with ISO 13485.
• Define equipment qualification requirements (IQ/OQ/PQ where applicable) and ensure proper calibration and maintenance programs are in place.
• Build and maintain data collection and reporting systems to ensure traceability, trending, and data integrity.
• Lead staffing of the QA Testing Lab, including hiring, onboarding, training, and competency qualification of technicians.
• Manage day‑to‑day lab operations, ensuring throughput, accuracy, and adherence to quality standards.
• Ensure all lab activities comply with ISO 13485 requirements for monitoring and measurement of product.

• Ensure proper identification, segregation, documentation, and disposition of nonconforming product.
• Maintain full traceability and data integrity for all breakage and scrap activities.
• Analyze breakage data and trends across surfacing, coating, finishing, and edging processes.
• Drive root cause investigations and CAPA activities to reduce scrap and improve yield.

• Plan and execute internal audits in accordance with ISO 13485 requirements.
• Audit manufacturing and inspection processes to ensure compliance with:
• Approved procedures and control plans
• Optical specifications and acceptance criteria
• Risk management controls
• Document audit findings and ensure timely corrective action and effectiveness verification.
• Support external audits (ISO certification bodies, FDA inspections, customer audits).

• Support and maintain the ISO 13485 Quality Management System.
• Ensure compliance with:
• Nonconforming product control
• Document and record control
• Training and competency requirements
• Change control and validation activities
• Manage the CAPA process
• Ensure all QA lab and production quality records are accurate, complete, and audit‑ready

• Ensure all products meet regulatory, customer, and internal quality requirements.
• Support complaint investigations, returns analysis, and quality event investigations.
• Maintain alignment with applicable FDA requirements and customer specifications.

• Define and track key performance indicators for the QA Testing Lab and overall quality, including:
• Test yield and throughput
• Breakage and scrap rates
• Defect trends and audit findings
• CAPA effectiveness
• Use statistical and trend analysis to identify risks and improvement opportunities for both the QA lab and manufacturing.
• Report quality performance and risks to leadership.

• Bachelor’s degree in Quality, Engineering, Manufacturing, or related field; or equivalent experience.
• 3–5+ years of experience in quality within a manufacturing environment.
• Demonstrated experience in lab setup, process development, or test method implementation
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• Prior…