Cypress HCM · 13 hours ago
Quality Assurance Specialist
Tustin, CA
Contract
Onsite
Mid Level
$80K/yr - $95K/yr
3+ years expCypress HCM is a growing company focused on the early detection of emerging diseases. The Quality Assurance Specialist is responsible for ensuring that products, processes, and documentation meet quality standards and regulatory requirements, while also managing quality system implementation and continuous improvement initiatives.
Human ResourcesInformation TechnologyStaffing Agency
Responsibilities
Develop, implement, and maintain the Quality Management System (QMS)
Plan, conduct, and coordinate internal and supplier audits to ensure compliance with regulatory and accreditation standards (e.g., CLIA, CAP)
Manage document control, change control, CAPA, nonconformance management, complaint handling, and MDR/Vigilance activities
Coordinate proficiency testing programs and analyze results to identify trends and improvement opportunities
Ensure all required regulatory licenses and accreditations remain current
Maintain quality documentation, SOPs, and laboratory testing procedures
Prepare, analyze, and present quality metrics and reports for management review
Train and onboard new personnel; review training documentation and monitor ongoing competency of testing staff
Maintain working knowledge of laboratory protocols, specimen processing, equipment operation and maintenance, and data analysis
Review and approve product labeling, packaging, promotional materials, and technical documentation for regulatory compliance
Monitor changes in global regulations, standards, and guidance; assess impact and recommend updates to internal processes
Partner with cross-functional teams (R&D, manufacturing, engineering, clinical, marketing) to embed quality and regulatory requirements early in product development
Lead or support management reviews, regulatory and quality training programs, and continuous improvement initiatives
Prepare, submit, and maintain regulatory filings, documentation, and reports
Coordinate with regulatory and accreditation bodies to support product approvals, certifications, and inspections
Ensure compliance with internal health and safety policies; report and address violations as required
Participate as an external auditor on College of American Pathologists (CAP) inspection teams, as required by the CAP accreditation program
Qualification
Required
Bachelor's degree (required) in life sciences, biology, chemistry, engineering, pharmacy, or related field; Master's a plus
3+ years of laboratory experience, including experience with audits, compliance systems, and regulatory submissions
Strong knowledge of key regulations and standards: FDA QSR (21 CFR Part 820/211), ISO 13485/9001, EU MDR/IVDR, GMP, ICH guidelines, etc
Working knowledge of relevant regulatory frameworks
Proven knowledge of quality assurance terminology, software, methods, and tools
Strong analytical, problem-solving, and decision-making skills
Experience in compliance and/or regulatory and knowledge of laboratory standards and regulations
Experience with Microsoft Office Suite; Word, Outlook, Excel
Excellent written and verbal communication skills for agency interactions, technical writing, and cross-functional collaboration
Able to effectively present information and respond to questions from various stakeholders
Preferred
Professional certification is a plus (i.e, Regulatory Affairs Certification – RAC, ASQ Certified Quality Auditor – CQA)
CLS Generalist or CGMBS license preferred
Previous experience with Laboratory Information Management Systems is preferred
Proficient in QMS software (i.e. MediaLab, TrackWise, MasterControl or similar)
Company
Cypress HCM
Cypress HCM is a staffing and recruiting company providing technology and creative recruiting solutions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Mark Lillig
CEO
Philip Oommen
CFO
Company data provided by crunchbase