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VP Quality and Regulatory Affairs in Arlington, TX at Joerns Healthcare

Date Posted: 9/20/2018

Job Snapshot

Job Description

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.

At Joerns Healthcare, each eligible employee receives a competitive total compensation package including Medical, Dental, Vision, Life Insurance and Short Term Disability. Our employees also receive Paid Vacation and Holidays.
Position Summary

Reporting to the Chief Supply Chain Officer, the Vice President, Quality and Regulatory Affairs will provide global leadership for all aspects of Joerns Healthcare 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, efficiency, productivity, customer service, and regulatory compliance while demonstrating continuous improvement(s).
In collaboration with the CSCO, the VP, Quality & Regulatory Affairs will lead the development and drive the implementation of the overall quality and regulatory affairs strategy for the company’s global quality organization, and create the structure, systems and processes to enable ongoing success.  The VP, QRA will provide technical leadership, advice and counsel on a wide array of issues, and will possess the depth and breadth of experience necessary to lead and 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 QRA 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.

Job Requirements

  • Provide strategic operational insight and knowledge as a key member of the Supply Chain Operations team.  Work closely with the CSCO to dovetail the Quality and Regulatory Affairs strategy with the overall company strategy.  Requires capability of developing and planning a 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.
  • Establish a world class continuous improvement culture with state of the art techniques (e.g. Lean, Six Sigma).  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 the development, implementation and 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

  • 15+ years of progressive quality and regulatory affairs leadership experience in a FDA regulated medical device environment, including 10+ 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. 
  • Ability to travel up to 25% of the time.
  • 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 excellent understanding of Quality and Regulatory Affairs requirements globally, specifically US and EU.
  • Proven expertise in the design and implementation of quality processes in a world-class medical device manufacturing organization.
  • Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance.
  • Must have technical competence and knowledge of medical device product design, manufacturing, process design and improvement and act as an open and accessible resource to peers.
  • Extensive relevant experience applying Quality risk management for medical device product development and manufacturing.
  • Knowledge of current FDA, EPA, ISO, Health Canada, and NHS guidelines.
  • 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 and facility working in a lean/kaizen culture, with a track record of utilizing these methodologies as a competitive advantage.
  • Hands-on, pro-active, with the vision to recognize opportunities and needs in the marketplace, and can react quickly to fill those needs.
  • 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 in a continuous improvement environment (e.g. Six Sigma, Toyota Production System, etc.).  Knows how to benchmark all areas of quality assurance and regulatory affairs.
  • Strong team-builder and mentor who is comfortable and experienced working in a fast-paced environment.
  • The combination of strategic thinking skills to lead the planning process, combined with strong execution leadership to drive results and hold people accountable.
  • Experience integrating quality and regulatory affairs functions from acquisitions / mergers.
  • 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 Chief Supply Chain Officer.
  • Requires expert knowledge in advanced QS/RA systems; SAP or Oracle environment.
  • Requires functional knowledge of selected business programs including word processing, spreadsheets, presentation programs, and other server based applications.

Preferred Skills, Experience & Education

  • Master’s degree preferred
  • Multilingual preferred (concentration in Spanish or German)

Joerns Healthcare is an Equal Opportunity Employer


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