Multi-Site Quality Director & CI Leader

Bisonametek; North Carolina; Hybrid; USD 150,000 - 190,000; Full time

Job summary

Bisonametek seeks a Director of Quality to lead the quality strategy across two manufacturing sites. You will ensure products meet customer expectations, regulatory standards, and certifications while driving continuous improvement.

This role requires building and sustaining QMS, guiding teams at Whitsett, NC and Reynosa, MX, and coordinating CAPA, process capability studies, and data‑driven decisions to reduce defects and costs.

Qualifications

• 10+ years in quality management within manufacturing.
• Experience with ISO 9001, AS9100, FDA or equivalent.
• Lean Six Sigma experience and continuous improvement mindset.
• Willingness to use AI tools to improve productivity and quality.

Responsibilities

• Develop and execute a strategic quality plan aligning with business goals.
• Lead and develop quality teams across two sites (Whitsett, NC & Reynosa, MX).
• Oversee QMS implementation, audits, CAPA, and regulatory compliance.
• Drive data‑driven decisions using SPC, FMEA, and control plans.
• Champion a culture of quality, accountability, and continuous improvement.

Skills

Leadership

Quality management

Strategic planning

Cross-functional collaboration

Education

Bachelor’s degree in Engineering/Quality Management

Master’s degree preferred

Tools

SPC

FMEA

8D

Root Cause Analysis

Job description

Job Description

As the

Job Description

As the Director of Quality, you will lead the quality strategy and continuous improvement efforts across all Bison manufacturing sites. You will be responsible for ensuring that the products meet or exceed customer expectations, industry standards, and regulatory requirements while driving overall quality performance and fostering a culture of continuous improvement. You will work closely with cross-functional teams to establish and maintain effective quality systems, drive process improvements, and ensure compliance with industry certifications.

This position can be based at either our Whitsett, NC or Reynosa, MX facility.

What You Will Do

• Leadership & Strategy
• Develop and execute a strategic quality plan in alignment with business unit goals.
• Lead, mentor, and develop a team of quality professionals across two locations, ensuring consistency in processes and objectives.
• Champion a culture of quality, accountability, and continuous improvement.
• Quality Management Systems (QMS)
• Oversee the implementation, maintenance, and improvement of the QAD Elements QMS and other relevant Quality Management Systems at both locations. Ensure compliance with customer, regulatory, and industry-specific quality standards (e.g., FDA, ISO, AS9100, etc.).
• Monitor and evaluate the effectiveness of quality management systems and propose enhancements to improve overall performance.
• Process & Product Quality
• Collaborate with sales, operations, engineering, and supply chain teams to identify drive resolution of quality issues, ensuring process and product integrity.
• Support root cause analysis and drive corrective and preventive actions (CAPA) for internal and external quality issues.
• Oversee first article inspections, process capability studies, and validation/qualification activities to ensure robust manufacturing processes.
• Continuous Improvement
• Lead Lean Six Sigma or other continuous improvement initiatives aimed at reducing defects, enhancing efficiency, and improving overall quality.
• Implement data-driven decision-making tools (e.g., SPC, FMEA, Control Plans) to monitor and improve process capabilities.
• Facilitate cross-functional value stream mapping sessions and quality workshops to drive process improvements.
• Customer & Supplier Relations
• Serve as the main point of contact for customer quality issues, audits, and feedback, ensuring timely and effective resolution.
• Oversee supplier quality management, including audits, performance monitoring, and supplier development initiatives.
• Metrics & Reporting
• Establish and track key performance indicators (KPIs) related to quality performance, including scrap/rework, defect rates, customer complaints, and audit findings.
• Regularly report quality performance metrics to senior leadership, highlighting trends and recommending corrective actions.
• Regulatory Compliance & Audits
• Lead internal and external audits, ensuring the sites comply with relevant standards and certifications.
• Ensure the manufacturing facilities are audit-ready at all times and coordinate responses to audit findings.
  

What We Are Looking For

• Bachelor’s degree in Engineering, Quality Management, or a related field. Master’s degree preferred.
• 10+ years of progressive experience in quality management within a manufacturing environment, with at least 5 years in a leadership role.
• Demonstrated experience with quality management systems (ISO 9001, AS9100, FDA, or equivalent) and continuous improvement methodologies (Lean, Six Sigma).
• Demonstrated ability and willingness to use AI tools to improve productivity, decision-making, work quality, and to reduce costs. The successful candidate must be able to identify appropriate AI use cases and critically evaluate AI-generated outputs.
• Proven track record of driving quality improvements across multi-site operations.
• Ability to travel as needed to the BU manufacturing sites (up to 30%)
• Strong leadership and team-building skills.
• Excellent analytical and problem-solving abilities.
• Ability to communicate effectively with all levels of the organization.
• Proficiency in quality tools such as SPC, FMEA, 8D, and Root Cause Analysis.