QA & Regulatory Compliance Specialist

Cypress HCM; Tustin (CA); On-site; USD 80,000 - 95,000; Full time

Job summary

A leading healthcare company is seeking a Quality Assurance Specialist in California. The role involves developing and maintaining a Quality Management System, conducting audits, and ensuring compliance with regulatory standards. Candidates should hold a Bachelor’s degree in life sciences and have at least 3 years of relevant laboratory experience. Strong analytical and communication skills are essential, making this position pivotal for supporting product approvals and patient safety.

Qualifications

• 3+ years of laboratory experience, including audits and compliance.
• Proven knowledge of quality assurance terminology and methods.
• Professional certification is a plus (e.g., RAC, CQA).

Responsibilities

• Develop and maintain the Quality Management System.
• Plan and conduct internal and supplier audits.
• Prepare and present quality metrics for management.

Skills

Strong analytical skills

Problem-solving skills

Excellent communication skills

Regulatory knowledge

Quality assurance methods

Education

Bachelor's degree in life sciences or related field

Master's degree

Tools

Laboratory Information Management Systems

QMS software

Microsoft Office Suite

Job description

A leading healthcare company is seeking a Quality Assurance Specialist in California. The role involves developing and maintaining a Quality Management System, conducting audits, and ensuring compliance with regulatory standards. Candidates should hold a Bachelor’s degree in life sciences and have at least 3 years of relevant laboratory experience. Strong analytical and communication skills are essential, making this position pivotal for supporting product approvals and patient safety.