SOLUTION ARCHITECT L2

Posted today

wipro technologiesReedsville (OH)

Validation Engineers Computer Systems Design Services

SENIORITY

Lead

SALARY

$100,000 per year

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About the role

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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