Johnson & Johnson Careers
Director, Plant Quality
Requisition ID: 6518190607
Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Plant Quality to be based in San Angelo, TX.
The Ethicon business offers a broad range of products, platforms and technologies including sutures, clip appliers, and synthetic mesh devices
that are used in a wide variety of minimally invasive and open surgical procedures. 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 electiveness of open surgery.
The Director, Plant Quality serves as Management Representative for the plant. Leads the Quality System execution at the plant. Plans, executes and leads the Quality function for the site including quality systems, quality engineering, product release, corrective and preventive action and non-conformance system, complaint investigation, document control, training, as well as ensuring compliance with regulatory and company requirements.
- Achieve product Quality goals for the site
- Assure execution of the quality system at the plant, and utilize process excellence tools/ methodology for continuous improvement and predictability
- Maintain plant in compliance with applicable regional and global Quality System laws regulations and standards.
- Maintains a deep understanding of quality system regulations & standards related to the medical products manufactured at the site, including but not limited to US FDA 21 CFR parts 820 & 4, ISO13485, Canadian Medical Device Regulation, European Medical Device Directive, ANVISA, TGA, Japan MHLW 169 and China GMP.
- Responsible for compliance with all corporate regulatory, human resource programs, policies and procedures, and safety/environmental systems.
- Serve as Management Representative per ISO13485 & FDA QSR and as Responsible Engineering Manager per JPAL requirements for the plant.
- Performs audits to establish the level of compliance with regulations and standards in applicable Quality System of the Business elements in case of necessary.
- Report to top management on the performance of the quality management system and any need for improvement
- Ensure the promotion of the awareness of the regulatory and customer requirements throughout the manufacturing site.
- Effectively implement Quality System strategy defined by WW Quality System & Compliance.
- Ensure that the facility remains continually certified to ISO.
- Lead ISO and QSR compliance efforts within the facility.
- Have a thorough knowledge of Ethicon’s Quality System.
- Ensure that the Quality System is regularly audited/reviewed and that changes needed are implemented in a timely fashion.
- Serve as a resource by recommending appropriate compliance efforts and proposing improvements to the Quality System.
- Ensure all facility associates are educated in the regulatory requirements.
- Maintain plant in compliance with Quality System Regulations.
- Ensure plant have appropriate resources with the right competencies to execute the Quality System.
- Maintain systems that assure only acceptable raw materials are used in processes and that only acceptable materials are shipped. Has the authority to stop production/shipments if quality requirements have not been met.
- Provide timely information to Management on the status of conformance to requirements.
- Maintain an effective Quality Information System (Document Management, Nonconformances, etc).
- Review and act as approval authority or delegated authority, retaining responsibility for all specifications, protocols, validations, fact books, and non-conformances.
- Enforces, promotes and observes all safety, industrial hygiene rules and regulations established by the Company.
- Takes appropriate actions to build and maintain a working environment aligned with OUR CREDO.
- Follow all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).
- Support Quality Improvement Processes, Affirmative Action objectives and all activities to achieve World-class Manufacturing plant.
- Participate or support major plant projects, such as transfer of new product or process.
- Establish, and operate within, an effective budget and headcount plan for the QA organization.
- Recruit, select and develop adequate human resources.
- Support plant objectives in Safety, Health and of maintaining environmentally neutral operations.
- Scope of operation encompasses approximately 15 direct reporting personnel and an extended team for 55 - 70 employees on multi shift schedules.
- Direct subordinates typically are Quality Operations Managers, and CAPA / NCR Manager,
- Review and participate in personnel development programs necessary to provide employee movement through prescribed promotional patterns.
- Evaluate and recommend staffing requirements to insure maximum utilization of personnel to fulfill department objectives.
- Approve salary increase recommendations and recommends salary increases and promotions for direct subordinates, interviews applicants for job openings, conduct performance reviews and provides guidance to subordinates.
- Responsible for communicating business related issues or opportunities to next management level
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
- Bachelor’s degree required
- A master’s degree is preferred
- A minimum of 10 years in Quality Assurance and/or Medical Device Industry overall business experience.
- A minimum of 5 years in supervisory skills, preferably QA Exempt personnel is required
- Regulatory compliance knowledge and skills is required.
- Advanced Quality Systems knowledge is required.
- Interpretation and application of QSR and ISO Standards
- Excellent communication and interpersonal relation skills.
- Statistical and analytical problem solving.
- Advanced computer and use of software applications (s)
- Language Skills: English mandatory for all plants; Spanish mandatory for San Lorenzo and Juarez (San Angelo and Cornelia is optional)
- 20-30% domestic and international travel required. Weekend travel and work, and participation in conference calls and meetings during late night/early morning hours may be required occasionally.
- The San Angelo Plant is a 24/7 operation; weekends and holidays are included in the work schedule.
United States-Texas-San Angelo-
Ethicon Inc. (6045)