Joerns Healthcare

  • Director, Quality and Regulatory Affairs

    Job Location US-NC-CHARLOTTE | US-TX-ARLINGTON
    Posted Date 6 months ago(12/18/2018 4:15 PM)
    Type
    FTR Full-Time Regular
    Job ID
    2018-4283
    Address
    2430 Whitehall Park Dr. #100
    City
    CHARLOTTE
    Country
    US
    State/Province
    NC
    Postal Code
    28273
  • Position Summary

    In collaboration with the Chief Supply Chain Officer, the Director of Quality and Regulatory Affairs will provide global leadership for all aspects of Joerns Healthcare’s Quality and Regulatory Affairs function to include direction, management and coordination of all functions impacting quality and regulatory affairs department(s) and/or personnel.  The incumbent will serve as the key resource to drive achievement of enterprise objectives of quality, safety, and regulatory compliance while demonstrating continuous improvement(s).

     

    The job holder will champion the development and drive the implementation of the overall quality and regulatory affairs policies for the company’s global quality organization, and assure the structure, systems and processes are in place to enable ongoing success.  The Director, Q&RA will provide technical leadership, advice and counsel on a wide array of issues, and will contribute to the long-term profitability and success of the business.

     

    The incumbent will work closely with all functional areas of the organization to direct the effective execution of the Q&RA strategy as well as the ongoing continuous improvement initiatives.  The role will be responsible for the strategic management of the company’s QRA team and accountable for all deliverables respective of FDA, Health Canada, and NHS regulatory requirements.

     

    **Must be able to co-locate between Charlotte, NC and Arlington, TX**

    Major Duties & Responsibilities

    • Provide strategic operational insight and knowledge as a key member of the Supply Chain Operations team. Work under direction of the CSCO to ensure alignment of the Quality and Regulatory Affairs strategy with the overall company strategy.  Requires capability of planning and executing to the Quality & Regulatory Affairs strategy with aggressive, but reasonable, goals and milestones.
    • Function as the Official Correspondent/ Responsible Authority for all Joerns sites and the designated signatory for all regulatory agency interaction(s) for the FDA, Health Canada, and NHS systems.
    • Implement Quality & Regulatory Affairs systems, processes and controls to constantly monitor and ensure the quality, safety, regulatory compliance and continuous improvement of Joerns global product and services portfolio.
    • Drive quality and regulatory affairs improvements and compliance throughout the entire organization from design to delivery of Joerns products and services.
    • Develop and lead a strong quality & regulatory affairs team across the Joerns platform, providing effective leadership, support, training, and mentorship to Joerns quality & regulatory affairs organization.
    • Identify and implement opportunities to develop alternative quality and regulatory affairs solutions that lead to the continual reduction of the cost of quality.
    • Establish effective relationships cross-functionally across the company to integrate quality and regulatory affairs activities with the overall company goals, plans, and objectives. Supporting the CSCO, upgrade quality & regulatory affairs management to better coordinate the global quality management vision across manufacturing, supply chain, and commercial services.
    • Lead and direct the Regulatory Affairs function for Joerns insuring that mandated aspects are complied with and interface and coordinate with legal affairs related to product claims (lawsuits), subpoenas, depositions, exploratory calls and site visits by the Joerns legal team and/or legal partners.
    • Act as final signatory approval for all design control related documentation, technical file/CE Mark Declaration-of-Conformity, product and marketing literature, ISO documentation, product drawings and document change orders.
    • Act as final release authority for all newly developed or transitioned company product(s) ensuring all regulatory requirements have been met.
    • Develop and implement quality programs and strategies that enhance the organization’s quality assurance effectiveness, lower operating costs, and improve overall quality and product safety.
    • Develop and implement regulatory affairs systems and strategies that ensure compliance with all applicable regulatory guidelines and agency statutes and assure Joerns products and services remain compliant, registered, and approved for use.
    • Build strong relationships with internal and external customers to build, enhance, and ensure quality awareness and regulatory compliance.
    • Lead all monitoring of required site processes and competencies to ensure that quality standards are implemented in accordance with corporate goals.
    • Ensures the proper interface of the quality function to product development, manufacturing, supply chain, and other areas as required.

    Supervisory Responsibilities:

    • Provides overall supervision of Joerns Quality & Regulatory Affairs staff inclusive of Service Operations Quality, Site Quality Manager(s), Supplier Quality Engineering, Document Control, Quality/Regulatory Affairs, Continuous Improvement, and Failure Investigation.

    Required Education

    Bachelor’s degree (B.S.) in science, math or engineering discipline.

    Required Skills & Experience

    • 7+ years of progressive quality and regulatory affairs leadership experience in a FDA regulated medical device environment, including 5+ years of managing others.
    • Relevant certification(s) from recognized organizations such as ASQ (American Society for Quality), Global Regulatory Affairs Compliance Professional (GRACP) is a plus.
    • Lean and 6 Sigma certifications a plus.
    • Ability to travel up to 25% of the time.
    • English fluency; multilingual preferred (concentration in Spanish or German).
    • audiences of various sizes. As a representative of Joerns, professional demeanor is required at all times with internal and external interactions.
    • Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product development, manufacturing and commercial operations in a FDA regulated and ISO certified environment.
    • Has an advanced understanding of Quality and Regulatory Affairs requirements globally, specifically knowledge of current FDA, EPA, ISO, Health Canada, and NHS guidelines.
    • Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance.
    • Extensive relevant experience applying Quality risk management for medical device product development and manufacturing.
    • Proven history of building strong collaborative relationships with regulatory agencies.
    • Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization.
    • Extensive experience in GMP and other Regulatory compliance requirements.
    • Experienced in regulatory filings for US, EU and other key countries/regions.
    • Experience working in a lean/kaizen culture, with a track record of utilizing these methodologies as a competitive advantage.
    • Proven ability to develop people and instill a commitment to excellence throughout the organization. The capability to motivate employees to a high degree of performance, being a good listener with outstanding people skills, and possessing a high sense of personal values and integrity are essential.
    • Experience/training benchmarking all areas of quality assurance and regulatory affairs.
    • Excellent written and verbal communication skills, including the ability to successfully communicate with suppliers, customers and across staff levels.
    • Develop and be accountable for the assigned budget. Manage within corporate parameters including total limits, phasing of spend, potential adjustments due to business needs communicated by the CSCO.

    Preferred Skills, Experience & Education

    • Master’s degree preferred.
    • English fluency; multilingual in German, Dutch or Spanish is preferred.

    Joerns Healthcare is an Equal Opportunity Employer

    About Joerns

    Joerns Healthcare is a leading national distributor of therapeutic support surfaces, bariatric care equipment, negative pressure wound therapy systems, and safe patient handling solutions. We serve special patient handling needs across the entire continuum of care, including acute care hospitals, long term acute care hospitals, skilled nursing facilities, rehabilitation facilities, and hospice centers.

     

    We continually strive to provide the most exceptional service, the most affordable products, and the most innovative patient care solutions to our customers. We are currently searching for skilled, self-motivated and dedicated professionals to add to our team. We offer hands on training, benefits and an outstanding work environment.

    Benefits

    At Joerns Healthcare, each eligible employee receives a competitive total compensation package including Medical, Dental, Vision, Life Insurance and Short Term Disability.  In addition, the company offers a 401K program with a company match, and Flexible Spending Accounts.  Our employees also receive Paid Vacation and Holidays. 

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