• Manager, Compliance and Quality Assurance

    Job Location US-NV-Reno
    Job ID
    2018-13633
    # Positions
    1
    Posted Date
    2 weeks ago(4/9/2018 4:57 PM)
    Category
    Clinical Services (CS)
  • 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. Built on the legacy of James Edward Hanger, the first amputee of the American Civil War, Hanger is steeped in 150 years of clinical excellence and innovation with a vision to be the partner of choice for products and services that enhance human physical capability. Collectively, Hanger employees touch thousands of lives each day, helping people achieve new levels of mobility and freedom.

     

    Hanger, Inc. is an equal opportunity employer - female/minority/disability/vet.

    Could This Be For You?

    The Quality/Regulatory Assurance and Compliance Manager is responsible for all aspects of the ACP, ACPL and Innovative Neurotronics Quality systems and compliance to regulatory bodies.

    Your Impact

    • Provides leadership to the company concerning quality, regulatory and compliance affairs. Is responsible for establishing the Quality System to meet National and International laws and regulations.
    • Establish and maintain knowledge of US Governmental and International laws and regulations
    • Coordinate the continued development and implementation of the Quality System, including the policies and procedures to meet necessary requirements of the FDA and the European community as needed.
    • Ensure compliance with the Quality System (specifically to US FDA’s 21CFR, ISO 9001:2000, ISO 13485:2003, European Union MDD 93/42/EEC, and Health Canada’s CMDR) and other international requirements as they become applicable.
    • Act as lead auditor for the Internal Quality Audit program. Audit internal processes and external vendors as required by the quality system.
    • Oversee the coordination of all company activities regarding Government Regulatory Agencies, Notified Bodies, and testing laboratories.  This includes visits from regulatory agency personnel, submissions to government agencies and testing laboratories, development of Technical Construction Files and all responses to governmental regulatory agencies.
    • Drive ACP “Continual Improvement” Program. Ensure that department managers are updating procedures and processes to gain efficiencies and emphasis on consistency.
    • Report on status of the Quality System to the business leadership team.
    • Train personnel regarding Quality requirements and FDA laws and regulations and International Regulations.
    • Manage and lead the Quality team (Two Quality Control Inspectors and a Document Control Administrator)

    Minimum Qualifications

    Minimum

    • Bachelor’s degree or equivalent in related field

    • Minimum of 3 years experience and/or qualifications in Quality/Regulatory

    • A valid driver’s license and driving record within the standards outlined within Hanger’s Motor Vehicle Safety Policy and Procedures.

    Preferred

    • 3 to 5 years’ experience in FDA regulated industry
    • 3 to 5 years’ experience with ISO9001:2000 / ISO 13485:2003, European Union and Canadian Regulatory requirements.
    • Knowledge of export regulations

    Additional Success Factors

    • Detailed attention in job performance

    • Improvement on the quality system

    • Good attitude, work ethic and natural leadership

    • Achievement of an advanced degree or certifications

    • Excellent written and verbal communication

    • 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 salary.
    • Competitive health and insurance benefits.
    • Annual target bonus or commission.
    • Paid vacation and sick time.
    • Frequent company update talks with our leadership team.

     

     

    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 fully 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.​​

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