Quality Assurance Manager

Tentamus California•Irvine, CA

8d•$90,000 - $110,000•Onsite

About The Position

The Quality Manager at Tentamus California is responsible for administering, overseeing, and maintaining the Quality Management System (QMS) to ensure compliance with applicable regulatory, accreditation, client, and company requirements. This role supports laboratory operations by promoting quality assurance initiatives, continuous improvement activities, and adherence to industry standards while fostering a culture of quality throughout the organization.

Requirements

Authorized to work in the United States indefinitely without restriction or sponsorship
Bachelor's degree in Quality Assurance, Chemistry, Biology, Microbiology, Life Sciences, or related field preferred.
Minimum of 3 to 5 years of quality management or laboratory quality assurance experience preferred.
Working knowledge of ISO standards, FDA regulations, GMP/GLP practices, and laboratory quality systems.
Strong analytical, organizational, and problem-solving skills.
Excellent written and verbal communication skills.
Ability to manage multiple priorities and work effectively in a fast-paced environment.
Experience conducting audits, investigations, and CAPA management preferred.
Proficiency in Microsoft Office Suite and quality management software systems.
Demonstrated experience ensuring compliance with regulatory, safety, and quality standards in an accredited laboratory environment.

Nice To Haves

ASQ certificate preferred

Responsibilities

Manage and maintain the laboratory Quality Management System (eQMS) in accordance with company policies, regulatory requirements, and accreditation standards.
Timely cursory review and release of data to clients. This position is in charge of their departments communication with the rest of the laboratory on quality delays.
Communicate with account managers and clients on delays of testing and outstanding issues and investigations.
Ensure compliance with applicable FDA, ISO, GLP/GMP, CAP, CLIA, and other relevant quality and regulatory standards as applicable to laboratory operations.
Develop, review, revise, and implement Standard Operating Procedures (SOPs), quality policies, forms, and controlled documents.
Coordinate internal audits, external audits, inspections, and accreditation activities, including corrective action follow-up and documentation.
Lead investigations related to non-conformances, deviations, complaints, and corrective/preventive actions (CAPA).
Monitor quality metrics and trends to identify opportunities for process improvement and operational efficiency.
Collaborate with laboratory management and department leaders to ensure quality objectives and compliance standards are consistently achieved.
Provide guidance and training to employees regarding quality systems, regulatory compliance, and company procedures.
Maintain document control systems, training records, and quality-related documentation.
Participate in risk assessments, root cause analyses, and continuous improvement initiatives.
Support client audits and respond to quality-related inquiries or concerns in a professional and timely manner.
Ensure timely reporting, record retention, and compliance with company and regulatory requirements.
Promote a culture of safety, quality, accountability, and continuous improvement within the organization.
Establish procedures for maintaining high standards, reliability, and safety.
Determine and enforce, through functional groups, quality requirements in accordance with real company needs, based on current regulations including ISO/IEC 17025, FDA and all other accrediting/ certifying agencies.
Directly supervises Quality Department team members and responsible for hiring, performance management, and disciplinary actions.