QA Project Leader

QA Project Leader

Job :  | Positions: 1 |

Location:

Reno, NV | Type:
Full-Time

With a mantra of Empowering Human Potential, Hanger, Inc. is the world’s premier provider of orthotic and prosthetic (O&P) services and products, offering the most advanced O&P solutions, clinically differentiated programs and unsurpassed customer service. Hanger’s Patient Care segment is the largest owner and operator of O&P patient care clinics nationwide. Through its Products & Services segment, Hanger distributes branded and private label O&P devices, products and components, and provides rehabilitative solutions to the broader market.

With 160 years of clinical excellence and innovation, Hanger’s vision is to lead the orthotic and prosthetic markets by providing superior patient care, outcomes, services and value. Collectively, Hanger employees touch thousands of lives each day, helping people achieve new levels of mobility and freedom.

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

• 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.

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.

• Proven track record in Quality, Compliance, Regulatory Affairs.
• Strong customer service and public relations skills.
• Strong verbal and written communication skills.
• Solid computer skills.
• Familiarity with QA inspection tools.
• Act with integrity in all ways and at all times, remaining honest, transparent, and respectful in all relationships.
• Keep the patient at the center of everything that you do, building lifelong trust.
• Foster open collaboration and constructive dialogue with everyone around you.
• Continuously innovate new solutions, influencing and responding to change.
• Focus on superior outcomes, and calibrate work processes for outstanding results.

• Competitive Compensation Packages.
• 8 Paid National Holidays & 4 additional Floating Holidays.
• PTO that includes Vacation and Sick time.
• Medical, Dental, and Vision Benefits.
• 401k…