TEST ENGINEER L3(CONTRACT)

Wipro; Reedsville (OH); On-site; USD 66,000 - 110,000; Full time

Job summary

Wipro Limited in Reedsville, PA (Day 1 onsite) seeks a Quality Engineer to develop multi‑module test cases, set up test environments, and prepare test evidence while validating system functionality for medical device projects. You will manage CAPA, nonconformance, and deviation activities; perform root cause analysis, data analysis, and support FDA readiness and audits.

Requirements include 8+ years of medical device quality experience and a Bachelor's degree in engineering; experience with

Qualifications

• CAPA, Nonconformance, and Deviation management experience.
• Root Cause Analysis methods (5 Whys, Fishbone, FTA).
• Quality Metrics and Trend Analysis proficiency.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Design Controls and Validation support experience.

Responsibilities

• Manage CAPA, Nonconformance, and Deviation activities.
• Conduct Root Cause Analysis and corrective actions.
• Review quality metrics and identify recurring issues.
• Support quality audits and FDA readiness programs.
• Collaborate with cross-functional teams on quality improvements.

Skills

CAPA management

Nonconformance management

Deviation management

Root cause analysis

Quality metrics & trend analysis

Regulatory knowledge

Education

Bachelor's degree in Engineering

Job description

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients’ most complex digital transformation needs. Leveraging our holistic portfolio of capabilities in consulting, design, engineering, and operations, we help clients realize their boldest ambitions and build future-ready, sustainable businesses. With over 230,000 employees and business partners across 65 countries, we deliver on the promise of helping our customers, colleagues, and communities thrive in an ever-changing world. For additional information, visit us at www.wipro.com.

Job Description

Role Purpose

The purpose of this role is to develop multi-module test cases and set up test environments while preparing test evidence and validating system functionality.

Role: Quality Engineer

Location: Reedsville, PA (Day 1 Onsite)

Job Summary: Support quality remediation and compliance initiatives by managing nonconformance, CAPA, deviation, complaint handling, and quality system activities. Perform quality assessments, root cause investigations, data analysis, and quality improvement initiatives while ensuring compliance with medical device regulations and standards

Key Responsibilities

• Manage CAPA, Nonconformance, and Deviation activities.
• Conduct Root Cause Analysis and corrective actions.
• Review quality metrics and identify recurring issues.
• Support quality audits and FDA readiness programs.
• Collaborate with cross-functional teams on quality improvements.

Required Skills

• CAPA, Nonconformance, and Deviation Management.
• Root Cause Analysis (5 Why, Fishbone, FTA).
• Quality Metrics and Trend Analysis.
• FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Design Controls and Validation Support

Preferred Qualifications

• Bachelor's degree in Engineering discipline.
• 8+ years of Medical Device Quality experience.
• Experience with Class II/III medical devices.
• Experience supporting FDA, MDSAP, and ISO audits

Mandatory Skills: Medical Regulatory and Process Standards. Experience: 3-5 Years.

The expected compensation for this role ranges from $45,000 to $110,000 . 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.

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.

Reinvent your world. We are building a modern Wipro. We are an end-to‑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.