Senior CAPA Specialist
$78,000–$156,000 year
On-siteIrving, Texas, United States
Job Summary
Facilitate, execute, and improve the CAPA process by communicating with management, peers, and stakeholders to escalate quality issues. Lead or participate in CAPA projects, ensuring compliance, quality, and timeliness of records while collaborating on Six Sigma root cause analysis. Independently investigate issues, gather data, perform preliminary analysis, and process requests with timely responses and approvals. Lead meetings for CAPA updates, assist with metrics reporting, and support team training. Provide subject matter expertise during audits and inspections, contribute to continuous improvement initiatives, and mentor lower-level engineers. Execute Quality Assurance engineering deliverables in alignment with FDA regulations and company policies.
Required Qualifications
- Bachelor's degree preferably in engineering, healthcare, science fields, or an equivalent combination of education and work experience
- Minimum 6 years significant engineering and/or technical operational experience plus demonstrated competence
- Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies
- Prior medical device experience
- Experience with assay, reagents, assay files
- Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016
- Solid communication and interpersonal skills
- Strong technical writing skills
- Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
- Advanced computer skills, including statistical/data analysis and report writing skills
Desired Qualifications
- Master's degree preferred
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