QA Analyst III

Hanger; Reno (NV); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Competitive Compensation Packages

8 Paid National Holidays & 4 additional Floating Holidays

PTO including Vacation and Sick time

Medical, Dental, and Vision Benefits

401k Savings and Retirement Plan

Flexible Work Schedules

Relocation Assistance

Job summary

Hanger is seeking a Quality/Compliance Regulatory Affairs Specialist for their Reno, NV location. The role involves maintaining the Quality Management System and ensuring compliance with national and international regulations.

The ideal candidate will have a Bachelor’s degree and a minimum of 5 years’ experience in the FDA regulated industry. Hanger offers a competitive compensation package along with benefits such as PTO, medical, and 401k plans.

Qualifications

• Bachelor’s degree in a related field or equivalent work experience.
• Minimum of 5 years’ experience in FDA regulated industry and Regulatory Affairs.
• Lead auditor training required.

Responsibilities

• Responsible for maintaining and improving the Quality Management System.
• Create and process CAPAs in a team environment.
• Monitor and maintain the Device Investigation response.

Skills

Quality Management System

Regulatory Affairs

Leadership

Customer Service

Communication Skills

Education

Bachelor’s degree or equivalent experience

Tools

Master Control QMS software

FDA compliance tools

Job description

Why Us?

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.

Could This Be For You?

To serve as a quality/compliance, regulatory affairs specialist and inspector for all aspects of the organization.

Your Impact

• 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.

Minimum Qualifications

• 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

Additional Success Factors

• 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.

Our Investment in You

• 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

Hanger, Inc. is committed to providing equal employment opportunity in all aspects of the employer-employee relationship. All conditions and privileges of employment are administered to all employees without discrimination or harassment because of race, religious creed, color, age, sex, sexual orientation, gender identity, national origin, religion, marital status, medical condition, physical or mental disability, military service, pregnancy, childbirth and related medical conditions, special disabled veteran status, or any other classification protected by federal, state, and local laws and ordinances. The company will comply with all applicable state or local fair employment laws that forbid discrimination or harassment on the basis of other protected characteristics. Retaliation against any employee for filing or supporting a complaint of discrimination or harassment is prohibited.