ABOUT THIS ROLEQuality Manager drives the organizations Quality Management Systems (QMS) through consistent, documented processes to ensure products and services exceed customer expectations. With integration of ISO 9001 (globally) recognized standard for Quality Management Systems and ISO 13485 (internationally recognized standard for Quality Management Systems designed for the medical device industry) practices, this role leads continuous improvement, manages internal and external audits and leads corrective actions to minimize defects and operational waste.
LOCATION AND SCHEDULEDurham, NC
Monday-Friday 7:00 AM - 4:00 PM
Travel up to 25% of the time to company manufacturing locations
KEY RESPONSIBILITIES- QMS Leadership and ISO Compliance. Lead the program and maintenance of the QMS in full alignment with the ISO 9001 and ISO 13485 standards. Act as primary point of contact for external auditors, certification entities and customers representatives during quality audits.
- Continuous Improvement. Assist the process Champion using risk-based thinking per ISO guidelines to identify areas for operational improvement, optimizing cost efficiencies and reduction of scrap and rework.
- Process Documentation. Oversee document control ensuring that standard operating procedures (SOP's), 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 (KPI's). Track, analyze and report QMS performance data to senior leadership and 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.
QUALIFICATIONS- Bachelor's degree in Engineering, Quality Management or a related technical discipline preferred.
- Minimum 10 years of related experience in QA/QC management with 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 (SPS)
- Must have excellent verbal and written communications abilities with a proven skill in translating quality data into actionable executive presentations.
Why LCI?- Purpose-driven company driven by principles, not profit
- Reach your highest potential: 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)
