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
- 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
- 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
- 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
- Supports the site in the investigation,
evaluation and implementation of actions to eliminate root causes of non
- 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
- Evaluates and recommends staffing
requirements to insure maximum utilization of personnel to fulfill department
- 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.
- 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
- Knowledge of lean manufacturing and
manufacturing processes such as Just in Time (JIT), KANBAN, and Pull Systems
- Excellent communication and interpersonal
relation skills are required. Statistical and analytical problem solving skills
- 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
- 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.
United States-Texas-San AngeloOrganization
Ethicon Inc. (6045)Job Function