Ethicon Endo- Surgery, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Quality Systems Specialist, 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 Senior Quality Systems Engineer at Torax Medical, Inc. will be responsible for developing and maintaining quality engineering systems in support of internal initiatives and changing external requirements. These activities may include audit responses, internal continuous improvements, or required quality system changes based on standards changes. You will work directly with internal and external customers to ensure quality system requirements are met. You are also responsible for following applicable Torax Medical Inc. and Ethicon quality system practices and completing all specific training requirements.
- Ensure Quality Systems in place are designed to meet regulatory requirements
- Benchmark best practices with world class organizations
- Interface with Notified Body, and/or other regulators
- Provide input to establish metrics
- Communicate information on regulatory requirements, lessons learned, and procedural changes to appropriate associates
- Manage continuous improvement projects as assigned, may include projects for departments other than Quality Compliance
- Provide input and direction to management on regulatory policy-level changes
- Develop and implement corporate-wide regulatory training programs
- Interface with Internal Auditors
- Ensure implementation of new or changed processes
- Administer CAPA and NM systems
- Perform other duties as assigned
- Bachelor’s Degree in Life Science, Engineering, Physical Science, or related technical areas may be considered.
- Qualified candidate must possess:
- Quality systems engineering experience; a minimum of 5+ years medical device or other regulated industry (automotive, Pharmaceutical, aerospace, and/or defense, etc.) is required
- Technical understanding with the ability to analyze information is required.
- Engineering experience and demonstrated use of Quality tools/methodologies (e.g.. Non-conformances material, CAPA, changing procedures based on changing regulations) is required
- Detailed knowledge of FDA, GMP, ISO 13485/ ISO 90001, MDD/MDR is required
Specialized Knowledge and Skills:
- Project management encompassing self-directed, highly organized and results-oriented skills with the ability to work with Torax internal cross-functional teams and external clients in a fast-pace, emerging growth organization
- Exceptional time management meeting corporate and departmental objectives
- Good communication skills to effectively present information both orally and in writing to diverse groups
- Good interpersonal skills with the ability to resolve problematic issues quickly and efficiently
- Ability to make timely and quantitative decisions
- Ability to persuade and motivate others
- Ability to effectively complete quality system training
- Process Excellence Certification (Six-Sigma/Lean Green Belt/Black Belt) is preferred.
- This position will be located in Shoreview, MN and may require up to 10% domestic travel.
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.Primary Location
Torax Medical, IncJob Function
Quality SystemsRequisition ID