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Hanger, Inc. · 2 weeks ago

QA Project Leader

Reno, NV

Full-time

Onsite

Senior Level

5+ years exp

Hanger, Inc. is the world's premier provider of orthotic and prosthetic services and products, dedicated to empowering human potential. The QA Project Leader will serve as a quality/compliance and regulatory affairs specialist, responsible for maintaining and improving the Quality Management System, ensuring compliance with national and international laws, and leading internal audits.

Health CareHospitalMedical Device

H1B Sponsor Likely

Responsibilities

Responsible for maintaining and improving the Quality Management System to meet National and International laws and regulations and pertinent quality standards

Ability to create and process CAPAs in a team environment

Ability to create programs, processes, and work instructions in a team environment

Establish and maintain knowledge of US Governmental and International laws and regulations affecting the organization’s products and operations

Proactively scans existing literature and FDA submissions to identify risk

Responsible for training program for yearly repeat trainings and Quality-related training

Monitor and maintain the Device Investigation response

Deal with FDA registration and 510K submission

Maintain GMDN, GS1, and GUDID submissions

Work with NPD team to create risk assessments and build quality into new product offerings

Lead the internal audit process with vendors and within internal functional areas as required. Ability to train new auditors

Maintains and further enhances a positive, engaged, accountable organizational climate

Actively engages with other internal functional areas and/or other affiliated Business Units to address and resolve issues for the organization

Projects a positive and professional image at all times

Assists in maintenance of Master Control QMS software processes

Inspects as needed

Performs audit, such as FDA, ISO, etc. unsupervised

Can run reports and gather data for AGW

Can assess the need for, and issue CAPAs when needed

Understands and can participate in improvements to the quality management systems

Can train/supervise and lead other employees

Qualification

Quality Management SystemRegulatory AffairsLead Auditor TrainingFDA SubmissionsLean / Six SigmaMaster ControlDigital QMSProject Management CertificateQA Inspection ToolsCustomer Service SkillsSolid Computer SkillsCommunication Skills

Required

Bachelor's degree in related field or equivalent work experience to substitute for the bachelor's degree

Minimum of 5 years' experience in FDA regulated industry and Regulatory Affairs

Lead auditor training required

Must have, or be eligible to obtain, a valid driver's license and driving record within the standards outlined within Hanger's Motor Vehicle Safety Policy and Procedures

Preferred

Lean / Six Sigma training preferred

Master Control knowledge a plus

Digital QMS knowledge a plus

Project Mgmt. Certificate a plus

Benefits

Competitive Compensation Packages

8 Paid National Holidays & 4 additional Floating Holidays

PTO that includes Vacation and Sick time

Medical, Dental, and Vision Benefits

401k Savings and Retirement Plan

Paid Parental Bonding Leave for New Parents

Flexible Work Schedules and Part-time Opportunities

Generous Employee Referral Bonus Program

Mentorship Programs- Mentor and Mentee

Student Loan Repayment Assistance by Location

Relocation Assistance

Regional & National traveling CPO/CO/CP opportunities

Volunteering for Local and National events such as Hanger’s BAKA Bootcamp and EmpowerFest

Company

Hanger, Inc.

Glassdoor3.5

Headquartered in Austin, Texas, Hanger, Inc. is a leading provider of orthotic and prosthetic (O&P) patient care services and products.

Founded in 1861

Austin, Texas, USA

5001-10000 employees

https://corporate.hanger.com/

H1B Sponsorship

Hanger, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2024 (1)

2022 (1)