Functional Consultant L4 Job Reedsville Ohio USA,Quality Assurance

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.

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Job Description Role Purpose

The purpose of this role is to develop end to end solutions for client business across modules and systemsbasisthe identified technical specifications, by conducting feasibility reviews anditsimplementation in alignment with cost and efficiency targets.

Role:
Quality Manager

Location:
Reedsville, PA (Day 1 Onsite)

Job Summary:

Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional teams.

Key Responsibilities:

Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs.
Support FDA inspections and regulatory audits.
Drive quality remediation and compliance initiatives.
Monitor quality metrics and management reviews.
Lead cross-functional quality improvement activities.

Required Skills:

Medical Device Quality Management Systems (QMS).
CAPA, Nonconformance, Complaint, and Audit Management.
FDA 21 CFR Part 820/QMSR and ISO 13485.
Risk Management and Design Controls.
Quality Metrics, Remediation, and Compliance Programs.

Preferred Qualifications:

Bachelor's or Master's degree in Engineering or related discipline.
12+ years of Medical Device Quality experience.
5+ years of Quality Management leadership experience.
ISO 13485 Lead Auditor or ASQ/CQI certification preferred.
Experience supporting FDA inspections and remediation programs

Mandatory

Skills:

Medical Regulatory and Process Standards.

Experience:

>10 YEARS.The expected compensation for this role ranges from $125,000 to $277,000 .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.

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