Johnson & Johnson Careers
Staff Lifecycle Management Quality Engineer
Requisition ID: 8570180801
Ethicon Endo- Surgery, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Staff Lifecycle Management Quality Engineer, located in Shoreview, MN, supporting Torax Medical.
Torax Medical specializes in developing and marketing medical devices designed to treat sphincter disorders utilizing its technology platform, Magnetic Sphincter Augmentation (MSA).
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. Torax Medical's core technology applies the unique properties of specialized magnets to precisely restore the barrier function of sphincters. Torax Medical’s technology platform, Magnetic Sphincter Augmentation, uses the attraction forces to augment weak or defective sphincter muscles to treat Gastroesophageal Reflux Disease (GERD) and Accidental Bowel Leakage (fecal or bowel incontinence).
You, the Staff Lifecycle Quality Engineer are responsible for support and leadership of Quality Engineering activities in Life Cycle Engineering, Sustaining Engineering, New Product Development, CAPA, and process improvement activities.
Some key job responsibilities include but are not limited to:
- Provide leadership in design & implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product.
- Provide leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems.
- Provide review and approval for the release of new products and design changes ensuring quality requirements are met.
- Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations.
- Act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers.
- Candidate must have strong analytical problem-solving skills and can assess effectiveness of corrective actions.
- Candidate must have sound statistical application in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc.
- A minimum of a bachelor’s degree is required. A degree in Engineering, Life Science, Physical Science or a related field is preferred; an advanced degree is an asset.
- A minimum of 6 years Quality experience or related experience is required.
- Experience in the medical device, pharmaceutical or other highly regulated industry is preferred.
- Knowledge of ISO and/or cGMP regulations is preferred. Experience in a FDA regulated environment 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.
- Experience in statistical methods, and data analysis is required. Sampling Planning, Risk Assessment and Process Validation is required
- Excellent written and oral communication skills are required. Ability to organize and follow up on multiple priorities is a must. Ability to respond to shifting priorities through appropriate realignment of required tasks and resources is a must. The ability to make solid decisions that will effectively support the business and company policies. The ability to work in a self-paced environment and provide leadership to team as appropriate is required.
- Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations. Knowledge of Failure investigation/ Design Failure Mode Effects and Analysis is required.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Torax Medical, Inc