Director, Quality Assurance
Location:
San Angelo , Texas
Posted:
January 27, 2017
Reference:
8847161021-en-us

Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Director, Quality Assurance to be located in San Angelo, TX.


The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures, and energy based surgical devices.  Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of surgery. Ethicon Endo-Surgery, Inc. was started within Ethicon, and was separated and moved to Cincinnati, Ohio over 20 years ago, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today along with innovative energy devices for surgery.

The Director, Quality Assurance will report to the Sr. Director Quality Operations Ethicon Raw Materials & Finished Goods, and serve as Management Representative for the plant.


The Director, Quality Assurance will be responsible for the following tasks:

  • Establishes and maintains Quality System procedures and controls ensuring that performance and quality of the product conforms to established company and regulatory standards. 
  • Develops and disseminates strategy for talent attraction, development and retention to enhance the Quality Operation talent pipeline. 
  • Provides active link and partnership between the sites, franchise partners, regions and corporate functions. 
  • Partners with the respective management for their sphere of influence to develop and support initiatives and responses to internal issues. 
  • Executes responses to field actions and coordinates global response with the franchise Quality leadership and corporate functions.
  • Ensures site assesses Quality System effectively through internal audit and Management review and implements corrective/ preventive, improvement actions as appropriate. 
  • Ensures site address customer feedback and complaints in appropriate and timely manner. 
  • Ensures that the site’s implementation of Quality Systems and goals are integrated in a cost effective and productive manner. 
  • Establishes and monitors metrics for the measurement of Quality indicators and Quality Costs to ensure effectiveness and value to the business. 
  • Leads the site staff in the understanding, development and deployment of key strategies, continuous improvement and customer focus. 
  • Supports the site in the investigation, evaluation and implementation of actions to eliminate root causes of non conformances. 
  • Possesses the necessary independence, authority and responsibility to initiate action to prevent nonconformities, enact remediation plans, identify and document quality problems, initiate, recommend, provide and verify solutions to quality problems and direct or control further processing and delivery of nonconforming product.
  • Ensures appropriate resources with the right competencies to execute the Quality System. 
  • Reviews and participates in personnel development programs necessary to provide employee movement through prescribed promotional patterns. 
  • Evaluates and recommends staffing requirements to insure maximum utilization of personnel to fulfill department objectives. 
  • Approves salary increase recommendations and recommends salary increases and promotions for direct subordinates, interviews applicants for job openings, conducts performance reviews and provides guidance to subordinates.



Qualifications

Qualifications:

  • A minimum of a Bachelor degree is required. An advanced degree is preferred.
  • A minimum of 10 years of overall related business experience in a healthcare regulated environment is required with the preference experience in drug and/or device related industries.  A minimum of 5 years of direct report people management experience is required.
  • Regulatory compliance knowledge and skills are required. Advanced Quality Systems knowledge is required. Product knowledge is preferred. Interpretation and application of QSR and ISO Standards are required.
  • Knowledge of lean manufacturing and manufacturing processes such as Just in Time (JIT), KANBAN, and Pull Systems are preferred.
  • Excellent communication and interpersonal relation skills are required. Statistical and analytical problem solving skills are required.
  • The ability to influence at senior levels and across functions building strong networks internally and externally is required.  Strong experience and proven record motivating leading and developing staff, in a highly changing environment is required. Change management skills are strongly preferred.
  • Prior project management experience is highly preferred.
  • An ASQ certification (CQE, CQM, CRE or CQA) is an asset.  Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
  • This position will be located in San Angelo, TX and require up to 15% of both domestic and international travel. 


Primary Location
United States-Texas-San Angelo
Organization
Ethicon Inc. (6045)
Job Function
Quality Assurance

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