Quality Engineer

Job description

Ethicon LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer.

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. 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 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.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

As the Quality Engineer, you will:

· Provide Quality Engineering and technical consulting to corporate, plant, and Research & Development as needed.
· Ensure compliance with applicable company policies and procedures such as Design Control, Validations, Sampling Plans, among others.
· Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Root Cause Analysis, Statistical Analysis and Design of Experiments (DOE) to improve products and processes; also, when solving process/product-related problems.
· Support validations and apply principles of metrology/calibration, reliability, and Computer System Validation (CSV) as required.
· Provide support to Operations on Quality Assurance/Control issues. Conduct investigation, bounding, documentation, review and approval of non-conformances, Corrective and Preventive Actions (CAPAs) and customer complaints. Advance quality issues as appropriate.
· Partner with functional teams to ensure appropriate application of process validation, process control, and risk management.
· Develop, interpret and implement standard and non-standard sampling plans.
· Guide the design, development, and implementation of suitable quality systems for new or existing products and processes as well as facilitate the design transfer process between corporate and the site.
· Conduct internal and external audits, ensuring compliance to Quality System Regulations (QSR) and ISO 9000. Document, explain, review or analyze proposed changes considering the impact they may have on the process.
· Support or lead quality improvement initiatives such as process and product characterizations that could result in continuous/cost improvements.

Desired profile

Qualifications :

·  A bachelor's or higher degree in Engineering is required.
·  A minimum of one (1) year of Quality experience within a manufacturing regulated environment is required. Previous COOP and internship experience will be considered.
·  Experience working in the Medical Device industry is highly preferred.
·  Previous experience in validations and basic knowledge in statistics is required.
·  Knowledge and experience applying Quality Engineering principles is required. Knowledge of Quality System Regulations and ISO 9000 is preferred.
·  Strong interpersonal and analytical skills are required.
·  Engineer-in-Training (EIT) or Professional Engineer (PE) license is preferred. Lean Six Sigma (e.g. Black/Green Belt) or ASQ Quality Engineer certifications are preferred.
·  Proficiency in Microsoft Office tools (Word, Excel, PowerPoint and Outlook) is required. Proficiency in Adaptiv and EtQ software is preferred.
·  Bilingual proficiency in English and Spanish (oral and written) is required.
·  This position requires up to ten percent (10%) of travel.