SOLUTION ARCHITECT L2

Wipro; Reedsville (OH); On-site; USD 100,000 - 200,000; Full time

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

Job Description

Role Purpose

The purpose of this role is to define secure integration strategies, devise solution frameworks for enterprise systems, and identify infrastructure dependencies to enable efficient and compliant implementation.

Role: CAPA Facilitator

Location: Reedsville, PA (Day 1 Onsite)

Job Summary

Facilitate and manage the end-to-end CAPA process to ensure timely investigation, implementation, effectiveness verification, and closure of quality issues. Coordinate cross-functional teams, monitor CAPA metrics, support audit readiness activities, and maintain compliance with FDA and ISO quality system requirements.

Key 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.

Required Skills

• 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.

Preferred Qualifications

• Bachelor's degree in Engineering or Life Sciences.
• 8+ years of Medical Device Quality Systems experience.
• Minimum 3 years of CAPA management experience.
• Experience supporting regulatory audits and inspections.

Mandatory Skills: System engineering -Mech engineers. Experience: >10 YEARS.

The expected compensation for this role ranges from $100,000 to $200,000 .Final compensation will depend on various factors, including your geographical location, minimum wage obligations, skills, and relevant experience.

Based on the position, the role is also eligible for Wipro's standard benefits including a full range of medical and dental benefits options, disability insurance, paid time off (inclusive of sick leave), other paid and unpaid leave options.

Applicants are advised that employment in some roles may be conditioned on successful completion of a post-offer drug screening, subject to applicable state law.

Information at a Glance

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Wipro provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Applications from veterans and people with disabilities are explicitly welcome.

Wipro offers a culture that encourages reinvention. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, caste, creed, religion, gender, marital status, age, ethnic and national origin, gender identity, gender expression, sexual orientation, political orientation, disability status, protected veteran status, or any other characteristic protected by law.

Wipro is committed to creating an accessible, supportive, and inclusive workplace. Reasonable accommodation will be provided to all applicants including persons with disabilities, throughout the recruitment and selection process. Accommodations must be communicated in advance of the application, where possible, and will be reviewed on an individual basis. Wipro provides equal opportunities to all and values diversity.