QA Project Leader

Hanger, Inc.•Reno, NV

59d

About The Position

To serve as a quality/compliance, regulatory affairs specialist and inspector for all aspects of the organization. This position is located in Reno, NV.

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.

Nice To Haves

Lean / Six Sigma training preferred
Master Control knowledge a plus
Digital QMS knowledge a plus
Project Mgmt. Certificate a plus

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.

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