CAPA & Quality Systems Solution Architect – Onsite

Wipro

Reedsville (OH)

On-site

USD 100,000 - 200,000

Full time

5 days ago
Be an early applicant
Application generator

An application made for this job — a tailored resume and cover letter that speak straight to the posting.

Get past ATS filters

Benefits offered by this job

Medical and dental benefits
Disability insurance
Paid time off

Job summary

Wipro Technologies is seeking a CAPA Facilitator to own and manage the end-to-end CAPA process, ensuring timely investigations, implementation, effectiveness verification, and closure of quality issues. You will coordinate cross-functional teams, monitor metrics, and support FDA/ISO quality systems.

The role requires extensive CAPA management experience, strong root cause analysis, and familiarity with eQMS. Onsite work in Reedsville, PA with a comprehensive benefits package is offered.

Qualifications

  • CAPA Lifecycle Management.
  • Nonconformance and Deviation Management.
  • Root Cause Analysis Techniques.
  • eQMS and Quality Metrics Reporting.
  • FDA 21 CFR Part 820, ISO 13485, ISO 14971.

Responsibilities

  • Manage CAPA lifecycle from initiation to closure.
  • Monitor CAPA timelines, aging, and effectiveness.
  • Facilitate CAPA review meetings and follow-ups.
  • Review CAPA documentation for compliance.
  • Support audit and inspection readiness activities.

Skills

CAPA lifecycle management
Nonconformance management
Root cause analysis
eQMS & quality metrics
FDA 21 CFR Part 820 / ISO 13485 / ISO

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Wipro Technologies is seeking a CAPA Facilitator to own and manage the end-to-end CAPA process, ensuring timely investigations, implementation, effectiveness verification, and closure of quality issues. You will coordinate cross-functional teams, monitor metrics, and support FDA/ISO quality systems.

The role requires extensive CAPA management experience, strong root cause analysis, and familiarity with eQMS. Onsite work in Reedsville, PA with a comprehensive benefits package is offered.

Get your free, confidential resume review.

or drag and drop your file here.

Similar jobs

Similar jobs worth comparing

Senior Medical Device QA Engineer: CAPA & FDA Readiness
Senior Medical Device QA Engineer: CAPA & FDA Readiness

Wipro • Reedsville (OH)

On-site
USD 45,000 - 110,000
Medical and dental benefits
Disability insurance
Paid time off
+2
SOLUTION ARCHITECT L2
SOLUTION ARCHITECT L2

Wipro • Reedsville (OH)

On-site
USD 100,000 - 200,000
Medical and dental benefits
Disability insurance
Paid time off
Senior Medical Device Test Engineer - CAPA & QA Lead
Senior Medical Device Test Engineer - CAPA & QA Lead

Wipro • Reedsville (OH)

On-site
USD 66,000 - 110,000
Senior CAPA & Quality Systems Engineer
Senior CAPA & Quality Systems Engineer

Planet Pharma • Draper (UT)

On-site
USD 72,000 - 1,325,000
Senior CAPA & Quality Systems Engineer
Senior CAPA & Quality Systems Engineer

Real Staffing Group • Virginia (MN)

On-site
USD 140,000 - 170,000
Health insurance
Retirement savings plan
Life and disability insurance
+1
Quality Engineer (CAPA)
Quality Engineer (CAPA)

Infosoft Inc. • Draper (UT)

On-site
USD 90,000 - 130,000
CAPA Quality Engineer - Root Cause & Compliance Pro
CAPA Quality Engineer - Root Cause & Compliance Pro

Infosoft Inc. • Draper (UT)

On-site
USD 90,000 - 130,000
Quality Engineer - CAPA & Root-Cause Leader
Quality Engineer - CAPA & Root-Cause Leader

Actalent • Mechanicsburg

On-site
USD 60,000 - 70,000
Health insurance
Retirement options
PTO 10 days
Quality Systems Engineer: CAPA & Investigations Lead
Quality Systems Engineer: CAPA & Investigations Lead

Contract Pharmacal Corp. • Hauppauge (NY), Northern (KY)

Hybrid
USD 80,000 - 110,000
GMP Quality Specialist - CAPA & Audit Lead
GMP Quality Specialist - CAPA & Audit Lead

PLZ Corp • Coal City (IL), Northern (KY)

Hybrid
USD 70,000 - 80,000
Medical benefits
401(k) with match
Paid time off