PRODUCT ARCHITECT L1(CONTRACT)

Wipro; Reedsville (OH); On-site; USD 80,000 - 158,000; Full time

Benefits offered by this job

Medical & dental benefits

Disability insurance

Paid time off

Job summary

Wipro Limited seeks a Product Architect L1 (Contract) in Ohio to lead manufacturing quality assessments for Class II/III medical devices, ensuring FDA/ISO/MDSAP compliance and CAPA-driven improvements. This role partners with delivery teams to drive risk management and process validation across regulated manufacturing environments.

The position demands 8–10 years of experience in medical device quality, with on-site collaboration in Reedsville, PA, and readiness for audits and inspections.

Qualifications

• 8–10 years of Medical Device Manufacturing Quality experience.
• Experience with Class II/III medical devices.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience supporting regulatory audits and inspections.
• Bachelor's or Master's degree in engineering.

Responsibilities

• Lead manufacturing quality assessments and process audits.
• Drive FPY improvement and defect reduction initiatives.
• Review IQ/OQ/PQ and risk management activities.
• Manage CAPA, nonconformance, and supplier quality issues.
• Support FDA, ISO 13485, MDSAP, and regulatory audits.

Skills

Manufacturing Quality Eng

Process Validation

SPC/MSA/PFMEA

CAPA & Nonconformance

FDA 21 CFR Part 820 & ISO 14971

Education

Bachelor's/Master's in Engineering

8+ years Medical Device QA

Job description

Job Title: PRODUCT ARCHITECT L1(CONTRACT)

State/Province: Ohio

Posting Start Date: 10/6/26

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 the role is to create exceptional product architectural design for the existing and new products and enable delivery teams to provide exceptional client engagement and satisfaction.

Role: Quality Lead

Location: Reedsville, PA (Day 1 Onsite)

Job Summary:

Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/III medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield improvement, CAPA effectiveness, quality metrics review, and manufacturing risk reduction programs across regulated manufacturing environments.

Key Responsibilities:

• Lead manufacturing quality assessments and process audits.
• Drive FPY improvement and defect reduction initiatives.
• Review process validation (IQ/OQ/PQ) and risk management activities.
• Manage CAPA, nonconformance, and supplier quality issues.
• Support FDA, ISO 13485, MDSAP, and regulatory audits

Required Skills:

• Manufacturing Quality Engineering.
• Process Validation and TMV.
• SPC, MSA, and PFMEA.
• CAPA and Nonconformance Management.
• FDA 21 CFR Part 820, ISO 13485, ISO 14971

Preferred Qualifications:

• Bachelor's/Master's degree in Engineering discipline.
• 8+ years of Medical Device Manufacturing Quality experience.
• Experience with Class II/III medical devices.
• Experience supporting regulatory audits and inspections

Mandatory Skills: Medical Regulatory and Process Standards.Experience: 8-10 Years.The expected compensation for this role ranges from $80,000 to $158,000 .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-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.