Top 3 Senior qa auditor Jobs in Durham, Nc

Manager, Quality
LCI —Durham, NC
- Monday to Friday
- Engineering
- Analysis skills
- Travel
- Wellness program
- Paid holidays
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11d
Senior Specialist 2, QC LIMS
FUJIFILM —Holly Springs, NC
- Call employer
- Microsoft Outlook
- ERP systems
- Bachelor's degree
12d

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Manager, Quality

LCI -
Durham, NC

Quick Apply

Job Details

11 days ago

Benefits

Wellness program
Paid holidays
Dental insurance
Paid time off
Employee assistance program
Vision insurance
401(k) matching
Life insurance

Qualifications

Statistics
Defect resolution root cause analysis
Statistical Process Control
Manufacturing facility experience
Statistical analysis
Biomedical regulatory compliance
Manufacturing company experience
Failure analysis

Full Job Description

ABOUT LCI

The mission of LCI 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 THIS ROLE

Quality 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 SCHEDULE

Durham, 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)

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

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senior qa auditor jobs in durham, nc

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Senior Specialist 2, QC LIMS

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