Jobs · Quality Assurance · North Carolina

Manager, Quality

LCI · Durham, NC · Yesterday
Quality AssuranceFull-time

About LCI

LCI’s mission is to provide meaningful employment for the blind and visually impaired. We accomplish this in four ways:

  • Employ: We are one of the largest employers of people who are blind, creating meaningful careers and lasting skills that transform their lives.
  • Build: We create over 2,000 products and distribute thousands more through manufacturing, retail, nationwide distribution, and e-commerce channels.
  • Serve: Many of our products are sold directly to the federal government. We were pioneers of “base supply centers,” stores on military bases that employ the blind and visually impaired and provide mission-critical supplies to our nation’s military.
  • Support: We want to end blindness forever. To that end, we engage in philanthropic efforts for research into blindness and treatment for the visually impaired.

About the Role

The Quality Manager drives the organization’s Quality Management Systems (QMS) through consistent, documented processes to ensure products and services exceed customer expectations. This role integrates ISO 9001 (globally recognized standard for QMS) and ISO 13485 (internationally recognized standard for QMS in the medical device industry) practices, leading continuous improvement, managing internal and external audits, and driving corrective actions to minimize defects and operational waste.

Schedule

Monday–Friday, 7:00 AM – 4:00 PM. Travel up to 25% of the time to company manufacturing locations.

Responsibilities

  • QMS Leadership and ISO Compliance: Lead the program and maintenance of the QMS in full alignment with ISO 9001 and ISO 13485 standards. Act as the primary point of contact for external auditors, certification entities, and customer representatives during quality audits.
  • Continuous Improvement: Assist process champions using risk-based thinking per ISO guidelines to identify areas for operational improvement, optimizing cost efficiencies and reducing scrap and rework.
  • Process Documentation: Oversee document control to ensure standard operating procedures (SOPs), work instructions, and quality records remain accurate, traceable, and compliant with ISO specifications.
  • Cross-Functional Collaboration: Partner with leadership, operations, and procurement teams to embed a quality culture and integrate ISO 9001 and ISO 13485 standards into daily workflows.
  • Auditing and Corrective Actions: Plan and execute comprehensive internal audit programs to ensure adherence to QMS, ISO 9001, and ISO 13485 guidelines. Manage the Corrective and Preventive Action (CAPA) system to investigate root causes, implement solutions, and verify effectiveness.
  • Performance Metrics (KPIs): Track, analyze, and report QMS performance data to senior leadership to drive evidence-based decision-making and continuous quality growth.
  • Contractual Review: Review contracts, product specifications, customer requirements, and contractual obligations to ensure all products consistently meet or exceed applicable quality standards, customer expectations, and regulatory requirements.
  • Other duties as assigned.

Requirements

  • Bachelor’s degree in Engineering, Quality Management, or a related technical discipline preferred.
  • Minimum 10 years of related experience in QA/QC management within a manufacturing or production environment.
  • ISO 9001 and 13485 Expertise: Strong working knowledge of ISO 9001 and ISO 13485 Quality Management Systems and quality principles.
  • Analytical Skills: Advanced proficiency with Root Cause Analysis (RCA), Failure Mode and Effects Analysis (FMEA), and Statistical Process Control (SPC).
  • Excellent verbal and written communication abilities, with a proven skill in translating quality data into actionable executive presentations.

Benefits

  • Purpose-driven company guided by principles, not profit.
  • Opportunities for upward mobility, rewarded through hard work.
  • Competitive salary and compensation.
  • Basic life insurance at no cost to the employee.
  • 401(k) with match and surplus-sharing plans.
  • Health, dental, and vision insurance.
  • Ten paid holidays annually.
  • Paid Time Off (PTO).
  • On-site health and wellness program.
  • Employee Assistance Program (EAP).

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