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

Unicorn Recruiter | Tech & Business Talent Specialist | People-First Hiring Partner | Empowering Careers, Enabling Growth @ Intellectt Inc

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)

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