Quality CAPA Specialist (contract)

The CAPA Specialist is responsible for overseeing and supporting the development, implementation, and management of corrective and preventive action (CAPA) processes in compliance with FDA regulations and other relevant industry guidelines. The individual will work cross-functionally with various departments to ensure that quality issues are investigated, root causes are identified, and effective corrective and preventive actions are implemented to maintain ongoing product quality and regulatory compliance.

Key Responsibilities

• Manage the end-to-end CAPA process, including root cause analysis, corrective actions, and preventive measures.
• Ensure that all CAPA activities comply with FDA regulations, Good Manufacturing Practices (GMP), and relevant ISO standards, specifically related to medical devices (e.g., 21 CFR Part 820) and pharmaceuticals.
• Investigate non-conformities, deviations, and complaints to determine root causes.
• Work proactively with teams to identify potential risks and implement preventive actions to reduce the occurrence of non-conformances.
• Work with cross-functional teams to implement effective corrective actions.
• Analyze historical data, adverse events, and complaint trends to identify areas for improvement in the design, manufacturing, or post-market monitoring of medical products.
• Maintain accurate and up-to-date CAPA records and reports.
• Prepare and present CAPA metrics, trends, and effectiveness reports to senior management.
• Analyze trends in CAPA data to identify potential systemic issues that require attention.
• Conduct training on CAPA procedures and best practices.
• Support internal and external audits by providing CAPA records and evidence of compliance.
• Monitor CAPA effectiveness and ensure timely closure.
  
  

Qualifications & Skills

• Bachelor’s degree in Engineering, Quality, or Life Sciences related areas.
• 4-6 years of experience in CAPA management, quality assurance, or regulatory compliance.
• Strong knowledge of root cause analysis tools (e.g., 5-Whys, Fishbone Diagram, FMEA).
• Strong understanding of medical device regulations (21 CFR Part 820), pharmaceuticals (21 CFR Part 210/211), and ISO 13485.
• Familiarity with regulatory compliance tools, such as risk management software and CAPA management systems.
  
  

The pay range that the employer in good faith reasonably expects to pay for this position is $25.43/hour - $39.73/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.

Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.