Quality Engineer I
Ethicon, Inc., a member of the Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer I to be located in San Angelo, TX.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies including sutures, surgical staplers, clip appliers, trocars 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 Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation.
The Quality Engineer I will work closely with business partners utilizing various Quality Engineering tools in the development and manufacture of new products as well the maintenance of current products, materials and processes. This individual will function as a quality representative on multi-functional product development teams in matters relating to Quality Engineering. Will support design control and process validation activities for new and change product efforts. This individual will ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sampling plans. This individual will lead and ensure the development of comprehensive risk management plans and operating procedures for the product and process. The Quality Engineer will ensure effective and comprehensive quality strategies. Will assist in thorough investigation of quality issues and oversee implementation of effective corrective and/or preventive action. The Quality Engineer will track/trend quality issues over time and generate reports to management and across sites. This Quality Engineer will provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures as well as medical device regulations.
Other Responsibilities
Provide technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems.
Provide support to J&J process excellence initiatives including Six-sigma & lean thinking.
Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations.
Ensure compliance with company policies and procedures including with all environmental, safety and occupational health policies. (i.e. ISO14001 & OSHAS18001).
A minimum of a Bachelor's degree in in Engineering, Life Science, Physical Science or a related field is required. An advanced degree is preferred.
Prior experience in quality engineering preferred.
Experience in the medical device, pharmaceutical or other highly regulated industry also preferred.
Knowledge of ISO and/or cGMP regulations is preferred.
New product development experience is preferred.
Supplier Quality Engineering experience is an asset. Sterilization process experience is an asset. General knowledge in Quality Systems Regulations (QSR) is an asset.
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.
Basic knowledge in statistics, sampling planning, risk assessment and process validation is preferred.
Technical writing experience is preferred.
Exposure to NCR's, root cause analysis, or IQ/OQ/PQ is preferred.
Leadership skills, either project or personnel based, are preferred.
This position may require up to 10% domestic or international travel and may require the ability to work some nights/ weekends/ holidays depending on business needs.
BE VITAL in your career, be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies including sutures, surgical staplers, clip appliers, trocars 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 Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation.
The Quality Engineer I will work closely with business partners utilizing various Quality Engineering tools in the development and manufacture of new products as well the maintenance of current products, materials and processes. This individual will function as a quality representative on multi-functional product development teams in matters relating to Quality Engineering. Will support design control and process validation activities for new and change product efforts. This individual will ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sampling plans. This individual will lead and ensure the development of comprehensive risk management plans and operating procedures for the product and process. The Quality Engineer will ensure effective and comprehensive quality strategies. Will assist in thorough investigation of quality issues and oversee implementation of effective corrective and/or preventive action. The Quality Engineer will track/trend quality issues over time and generate reports to management and across sites. This Quality Engineer will provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures as well as medical device regulations.
Other Responsibilities
Provide technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems.
Provide support to J&J process excellence initiatives including Six-sigma & lean thinking.
Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations.
Ensure compliance with company policies and procedures including with all environmental, safety and occupational health policies. (i.e. ISO14001 & OSHAS18001).
A minimum of a Bachelor's degree in in Engineering, Life Science, Physical Science or a related field is required. An advanced degree is preferred.
Prior experience in quality engineering preferred.
Experience in the medical device, pharmaceutical or other highly regulated industry also preferred.
Knowledge of ISO and/or cGMP regulations is preferred.
New product development experience is preferred.
Supplier Quality Engineering experience is an asset. Sterilization process experience is an asset. General knowledge in Quality Systems Regulations (QSR) is an asset.
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.
Basic knowledge in statistics, sampling planning, risk assessment and process validation is preferred.
Technical writing experience is preferred.
Exposure to NCR's, root cause analysis, or IQ/OQ/PQ is preferred.
Leadership skills, either project or personnel based, are preferred.
This position may require up to 10% domestic or international travel and may require the ability to work some nights/ weekends/ holidays depending on business needs.
BE VITAL in your career, be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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