- Entry level
- No Education
- Salary to negotiate
- San Angelo
Ethicon, Inc., a member of the Johnson & Johnson Family of Companies is recruiting for a Senior Quality Engineer located in San Angelo, TX.
The Ethicon 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 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. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The Senior Quality Engineer will work closely with business partners utilizing various Quality Engineering tools in the development and manufacturing 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. Support design control and process validation activities for new and change product efforts. 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. Lead and ensure the development of comprehensive risk management plans and operating procedures for the product and process.
Responsibilities will include:
Ensure effective and comprehensive quality strategies.
Assist in thorough investigation of quality issues and oversee implementation of effective Corrective and Preventive Actions (CAPAs).
Track/trend quality issues over time and generate reports to management and across sites.
Provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures as well as Medical Device regulations.
Assess, implement and monitor process capability for continuous improvement.
Lead cross-functional work teams and/or manage Quality Assurance (QA) technicians to include, direct daily supervision, performance appraisal, behavioral discipline, professional development and on- the-job training.
Provide technical expertise to ensure conformance to ISO, Food and Drug Administration (FDA) and Medical Device Directive (MDD) based quality systems.
Provide support to Johnson & Johnson Process Excellence initiatives including Six Sigma and Lean thinking.
Direct development and consistent application of quality policies and procedures in product design and development, secondary development, and transfer operations.
Ensure compliance with company policies and procedures including with all environmental, safety and occupational health policies. (i.e. ISO 14001 and OSHAS 18001).
A minimum of a Bachelor’s degree is required, preferably in Engineering, Life Science, Physical Science or a related field. Advanced degree preferred.
A minimum of 4 years of relevant experience is required.
Experience in Quality Engineering is preferred.
Experience in the Medical Device, Pharmaceutical or other highly regulated industry is preferred.
Knowledge of ISO and/or current Good Manufacturing Practice (cGMP) regulations is preferred. New product development experience is preferred.
Supplier Quality Engineering experience is preferred.
Sterilization process experience is preferred.
Knowledge of Quality Systems Regulations (QSRs) is preferred.
ASQ certification (CQE, CQM, CRE or CQA) is preferred.
Process Excellence/Six Sigma (Green or Black Belt) Certification is preferred.
Basic knowledge of Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred.
Must have excellent oral and written communication skills.
Must have strong analytical problem-solving skills,
This position may require up to 10% travel
Must have the ability to work some nights/we.ekends/holidays depending on business needs.
Johnson & Johnson is an Affirmative Action and Equal
About the company
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