Quality Assurance Director

Position Title : Quality Assurance Director

Department : Quality

Location : Santa Ana CA

FLSA Status : Exempt Full-Time

Job Summary :

The Quality Assurance Director provides strategic leadership for all quality functions and is responsible for developing implementing and maintaining the companys Quality Management System (QMS). Reporting directly to the President / CEO this role ensures the organization adheres to regulatory requirements industry standards and customer specifications. The Director drives continuous improvement oversees quality operations and supports companywide initiatives to enhance product reliability operational efficiency and customer satisfaction.

Key Responsibilities :

Provide leadership and direction for the Quality Assurance Quality Control and regulatory compliance functions.

Drive continuous improvement of the Quality Management System (QMS) to achieve and maintain AS9100 compliance.

Establish quality policies objectives KPIs and audit programs aligned with company strategy and customer expectations.

Oversee internal audits supplier audits customer audits and regulatory inspections; ensure timely corrective and preventive actions (CAPA).

Collaborate with engineering manufacturing supply chain and leadership teams to ensure quality is integrated throughout the product lifecycle.

Review and approve specifications inspection plans test methods and quality documentation.

Lead root-cause analysis and problem-solving initiatives to address product or process nonconformances.

Manage supplier quality programs including qualification incoming inspection monitoring and corrective actions.

Drive continuous improvement initiatives to enhance product quality reduce scrap / rework and improve operational efficiency.

Review customer requirements handle escalations lead quality discussions and ensure accurate timely response to customer concerns.

Provide training and mentorship to the quality team; build capability and promote a strong quality culture across the organization.

Prepare reports for executive leadership communicate quality performance trends and make data-driven recommendations.

Ensure all quality practices comply with federal state local and industry regulations as well as internal company procedures.

Incorporate experience within the EMS (Electronics Manufacturing Services) industry including proficiency with Net-Inspect and demonstrate a strong hands-on approach in daily activities.

Perform other executive-level responsibilities as assigned by the President / CEO.

Qualifications :

Bachelors degree in Engineering Quality or related technical discipline.

7 years of progressive quality management experience preferably in manufacturing or a regulated industry.

Strong knowledge of quality systems standards and regulatory requirements including AS9100.

Demonstrated leadership ability with experience managing teams and collaborating cross-functionally.

Expertise in root-cause analysis CAPA SPC Lean Six Sigma or similar tools.

Must be willing and able to obtain and maintain a security clearance if deemed necessary for the role.

Physical Requirements :

Ability to sit stand or walk for extended periods in office and production settings.

Ability to lift up to 2025 lbs occasionally.

Visual acuity for inspection reading technical documents and computer work.

Ability to work in manufacturing environments with moderate noise and movement.

This job description is intended to provide a clear overview of the primary duties and responsibilities for the Quality Assurance Director position. It is not an exhaustive list and other tasks may be required as needed to support the companys operations.

Regal Technology Partners is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants without regard to race color religion sex national origin age disability genetic information sexual orientation gender identity or any other characteristic protected by federal state or local laws. We strive to create an inclusive and diverse work environment where everyone is valued and respected.

If you require any accommodation during the application process or have any questions regarding our EEO policies please contact Human Resources

Required Experience :

Director

Key Skills

Quality Assurance,FDA Regulations,ISO 9001,Root cause Analysis,Biotechnology,Clinical Trials,Quality Systems,Food Processing,Quality Control,Quality Management,cGMP,HACCP

Employment Type : Full Time

Experience : years

Vacancy : 1