CAPA Execution Specialist/Investigator (Medical Device Manufacturing)

Job Title: CAPA Execution Specialist / InvestigatorLocation: Delaware (Onsite)

Employment Type: Contract (W2 / 1099)

Duration: 12-month contract (possible extension up to 24 months)Job Summary:

The CAPA Execution Specialist is responsible for executing corrective and preventive actions within a medical device manufacturing environment. This role focuses on hands-on investigation, root cause analysis, and implementation of corrective actions on the manufacturing floor, ensuring compliance with FDA and ISO standards.

Responsibilities

· Execute CAPAs end-to-end from investigation through closure

· Perform root cause analysis using tools such as 5 Whys and Fishbone

· Implement corrective and preventive actions on the manufacturing floor

· Work closely with assembly teams to ensure adherence to procedures

· Update SOPs, work instructions, and quality documentation

· Support document control activities including procedural updates

· Verify effectiveness of CAPAs and ensure sustainable solutions

· Collaborate with Quality, Manufacturing, and Engineering teams

· Manage multiple CAPAs in a fast-paced environment

Required Qualifications:

· Bachelor’s degree in Mechanical, Biomedical, Quality Engineering, or related field

· Hands-on experience executing CAPAs in medical device manufacturing

· Strong knowledge of root cause analysis methodologies

· Experience working on the manufacturing floor

· Knowledge of FDA regulations and ISO standards

· Experience with document control systems

Preferred Qualifications

· Experience with electromechanical assembly or capital equipment manufacturing

· Familiarity with Agile or hybrid document control systems

· Experience handling both manufacturing and system-level CAPAs

Salary:

The hourly rate for this position is US$40– $50 per hour.

Benefits

This is a contract position and does not include employer-provided benefits.

Equal Opportunity Employer:

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check:

Background checks may be conducted in accordance with applicable laws.

Work Authorization:

Applicants must be authorized to work in the United States.

If interested in this opportunity! Please send your resume to ahmed@intellectt.com or give me a call at +1-732-653-9472