Quality Assurance (QA) Manager
Location: Frisco, TX (On-Site)
Salary: $70,000 - $90,000 annually
Employment Type: Full-Time
Position Summary
We are seeking an experienced and detail-oriented Quality Assurance Manager to lead and maintain our Quality Management System (QMS) while ensuring compliance with ISO 17025 and ISO 9001 standards. The QA Manager will be responsible for overseeing quality processes, internal audits, equipment calibration programs, corrective and preventive actions (CAPA), and continuous improvement initiatives. This role requires strong leadership skills and a hands-on approach to quality assurance in a laboratory and/or manufacturing environment.
Key Responsibilities
- Manage and maintain compliance with ISO 17025 and ISO 9001 standards.
- Lead the Quality Management System (QMS) and drive continuous improvement initiatives.
- Plan, conduct, and document internal quality audits and support external audits and accreditation assessments.
- Develop, implement, and monitor corrective and preventive action (CAPA) programs.
- Oversee equipment calibration programs, ensuring all instruments are calibrated, maintained, and documented in accordance with quality requirements.
- Review quality records, procedures, work instructions, and technical documentation for compliance and effectiveness.
- Monitor quality metrics and KPIs and provide regular reporting to management.
- Investigate non-conformances, customer complaints, and quality-related issues, implementing corrective actions as necessary.
- Train employees on quality procedures, audit readiness, and regulatory compliance requirements.
- Collaborate with operations, engineering, and laboratory teams to improve processes and quality performance.
- Maintain document control systems and ensure all quality documentation is current and compliant.
- Serve as the primary point of contact for quality and accreditation-related matters.
Qualifications
Required
- Bachelor's degree in Quality, Engineering, Life Sciences, Industrial Technology, or a related field, or equivalent experience.
- 5+ years of quality assurance experience with at least 2 years in a leadership or management role.
- Strong working knowledge of ISO 17025 and ISO 9001 standards.
- Demonstrated internal auditing experience, including audit planning, execution, reporting, and follow-up.
- Proven expertise in equipment calibration programs, calibration records, and measurement traceability.
- Experience managing CAPA, root cause analysis, and continuous improvement initiatives.
- Excellent documentation, organizational, and communication skills.
- Proficiency with Microsoft Office Suite and quality management systems.
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.