Overview
Quality Engineer/CAPA Specialist Jobs in Santa Clara, California, USA at Intellectt Inc
Position: Quality Engineer (CAPA Specialist)
5 days ago Be among the first 25 applicants
Direct message the job poster from Intellectt Inc
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One of my clients is looking for a Senior Quality and Compliance Specialist (CAPA Specialist). If you’re interested or your skills match, please share your updated resume with me at
Role:
Senior Quality and Compliance Specialist (CAPA Specialist)
Duration: 1.5 Years
Note:
No C2C
We are seeking experienced Medical Device Quality Consultants with a minimum of 10 years of experience in Quality Management Systems (QMS) and Corrective and Preventive Actions (CAPA). This position supports post-audit quality improvements for a key client and offers an opportunity to enhance your resume with impactful work in the medical device sector.
Qualifications:
Minimum 10 years in QMS and CAPA within the medical device industry.
Extensive experience in medical device quality and compliance.
Strong expertise in CAPA processes, managing multiple CAPAs and resolving audit findings.
Deep knowledge of FDA QSR, ISO 13485, MDR/MDD, and other relevant regulations.
Familiarity with ISO standards and best practices.
Bachelor’s degree in a related field.
Preferred Qualifications:
Certifications in Auditing or CAPA.
Strong project management experience, especially in leading CAPA or audit projects.
Minimum 6+ years experience using MODA tools and methodologies.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering and Quality Assurance
Industries
Medical Practices and Medical Equipment Manufacturing
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Title: Quality Engineer/CAPA Specialist
Company: Intellectt Inc
Location: Santa Clara, California, USA
Category: Healthcare (Data Scientist), Quality Assurance – QA/QC (Data Analyst)