Hanger, Inc.

QA Project Leader

Hanger, Inc.

full-time

Posted on:

Location Type: Office

Location: Reno • Nevada • 🇺🇸 United States

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Job Level

Senior

About the role

  • 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.

Requirements

  • 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.
  • 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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
CAPArisk assessmentinternal auditFDA registration510K submissionGMDNGS1GUDIDquality management systemMaster Control QMS
Soft skills
team collaborationtrainingleadershipcommunicationproblem-solvingorganizational climate enhancementengagementaccountabilityprofessionalismsupervision
Certifications
Bachelor's degreeLead auditor trainingProject Management CertificateLean Six Sigma training