Senior Customer Quality Engineer

Johnson & Johnson Warsaw , IN 46581

Posted 2 months ago

At Johnson & Johnson we value talented, passionate and committed professionals. And we know sometimes those professionals leave the industry for a while. So, if you're a skilled technical leader who wants to get back up to speed and make your mark, our Re-Ignite Program is just what you are looking for. Re-Ignite has been carefully designed to help you build your capabilities, enhance your leadership skills and continue your professional journey. The program consists of a four-month assignment within Johnson & Johnson and will provide a direct opportunity to apply for full-time roles after successfully completing the program.

This program is part of a large initiative to increase the WiSTEM2D (Science, Technology, Engineering, Math, Manufacturing & Design) talent pipeline driven by the Society of Women Engineers and iRelaunch, a career re-entry firm.

DePuy Synthes Companies of Johnson & Johnson is recruiting for a Senior Customer Quality Engineer in Warsaw, Indiana.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offers unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials.

This position will support the DePuy Synthes Joint Reconstruction business unit, which offers orthopedic devices and solutions for hip, knee, and shoulder arthroplasty products. The Senior Customer Quality Engineer will lead key projects to improve department capability; improve quality of complaint data and decision making, and achieve Quality System tracked objectives (NC, CAPA, IA), Proactively collaborate and resolve cross-functional issues with stakeholders, and Collaborate with cross-Global Orthopedics companies, MD, and JNJ to identify and implement best, harmonized practices within Customer Quality.

The Senior Customer Quality Engineer will write and approve investigation reports after performing various investigational tasks in accordance with company procedures and quality systems regulations; develop customer correspondence when requested; partner with appropriate functional departments to achieve effective corrective actions and document within the complaint handling system; represent department on post-market surveillance reviews and safety management evaluations; participate on cross-functional and cross-company project teams to help drive consistency and process improvements across the business; interface with key business partners including R&D, Operations, Post Market Surveillance, Quality, Regulatory and Compliance, to insure complete and thorough investigations; serve as subject matter expert for regulatory audits.

The Senior Customer Quality Engineer is responsible for analyzing incoming product complaints, prioritizing investigations based on the event description and risk level, determining appropriate investigation plans and requirements, and partnering cross-functionally to find solutions to customer-reported quality issues.

Qualifications

  • Bachelor's Degree in Engineering required.

  • 6 Years Experience in an ISO regulated industry and/or GQP/GMP experience required.

  • 2 years away from a STEM related role.

  • An ability to work cross functionally and promote good working relationships.

  • The ability to work independently on routine tasks with high attention to detail is required.

  • The ability to demonstrate sound technical writing and business writing skills is required.

  • Medical/Pharmaceutical/Health Care Industry Experience is a plus.

  • Prior Experience with Root Cause Methodologies is preferred.

  • This role will be based in Warsaw, Indiana and may require up to 10% of domestic travel.

Primary Location

United States-Indiana-Warsaw-

Organization

Depuy Orthopaedics. Inc. (6029)

Job Function

Administration

Requisition ID
3791181004


upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Customer Quality Analyst

Johnson & Johnson

Posted 4 days ago

VIEW JOBS 1/18/2019 12:00:00 AM 2019-04-18T00:00 DePuy Synthes Companies of Johnson & Johnson is recruiting for an Associate Customer Quality Analyst. DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com. The Associate Customer Quality Analyst is responsible for assisting Customer Quality Analysts and Senior Analysts with the coordination of product complaint investigations. Responsibilities: * Analyze incoming product complaints. * Determination of requirements for investigation, the investigation and evaluation of complaints. * Finding solutions to customer issues by working interactively with cross functional teams. * Coordinate manufacturing history requests internally and with affiliates, complete stock audits, verify product code/lot code information, conduct complaint database searches as well as draft customer response letters. * Support the quality processes associated with product complaint handling, procedures, and controls to ensure that all complaints and complaint products are processed in accordance with established company procedures and worldwide regulations and standards. Qualifications * A minimum of a Bachelor's degree with a technical focus is required. * The ability to work independently on routine tasks with high attention to detail is required. * An ability to work cross functionally and promote good working relationships with other teams, to determine priorities, state challenges productively, and solve problems is required. * Previous Quality and/or Complaint Investigation experience is helpful. * A minimum of 2 years of related business experience (medical device, pharmaceutical or related healthcare industry) is a plus. * This position may require up to 10% domestic travel. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-Indiana-Warsaw- Organization Depuy Orthopaedics. Inc. (6029) Job Function Quality Assurance Requisition ID 2246190109 Johnson & Johnson Warsaw IN

Senior Customer Quality Engineer

Johnson & Johnson