ENGINEER 3 QUALITY ENGINEERING

Johnson and Johnson HCS Inc.
is recruiting for an Enginee 3 Quality Engineering, located in Mooresville, IN! At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
nj.
om/.
This individual will be accountable for development, oversight and execution of quality and compliance engineering and validation programs, facility and technology transfers and acquisition/divestitures to meet customer and business needs in compliance with regulatory requirements, Enterprise standards, Quality Management Systems at the MedTech Mooresville Distribution Center in the United States.
Sr.
Commercial Quality Engineer is responsible for supporting quality and compliance activities at the MedTech Mooresville Distribution Center, including validation activities, new product introduction, participating in NC investigations, and performing audit activities.
Key Responsibilities.
Defines, implements, and validates quality requirements and systems in alignment with departmental strategies and serves as the business expert on Quality Engineering for the Distribution Center and regionally In collaboration with key business partners and the 3PL, will identify opportunities to continuously improve quality, cost, and time factors, consistent with both Sector and Deliver business objectives Works as Quality liaison between J&J business and 3PL site for introduction of new products Identifies significant business issues, prioritizes for action, and leads improvement opportunities and problem solutions in addition to maintaining Quality operations at the Distribution Center Participating and leading investigations, remediation activities, standards development and implementation, audits, training, identifying preventive opportunities to continuously improve quality, cost and time factors and understanding current and emerging regulations and the impact to quality distribution practices Provide Quality support in all areas of the Distribution Center according to procedures and predefined agreements with Source Co., Franchise, or Marketing Co Provides specific technical expertise to support special projects, product/process improvements and provides input to develop capital expense forecast to support business needs for temperature sensitive and other opportunities Identifies and implements potential cost savings and project execution improvements Support local and Johnson & Johnson Enterprise quality and compliance initiatives and projects as needed Qualifications Education.
A minimum of a Bachelor's degree required, with a focus scientific or engineering focus preferred Experience and Skills.
Required.
A minimum of 4 years of regulated healthcare industry experience in distribution, transportation, temperature control, manufacturing, operations, regulatory and/or quality compliance is required Prior experience in an engineering role and experience working with an indirect organization that delivers results is required Understands the linkages in quality and regulatory compliance from product development through manufacturing and delivery to customer and health authority Builds consensus, can lead individuals through change and has strong project management experience Strong problem solving, decision-making, and root cause analysis skills Must have excellent interpersonal skills, and strong collaboration and influence skills to partner optimally across functions and operating units Makes the sophisticated clear and easily understood by others Flexible with ability to work independently and on teams, has excellent time management skills to prioritise multiple projects and deadlines Proven understanding of FDA 21 CFR Part 820 and ISO or MDSAP and WMS, ERP systems are requirements Preferred.
Six Sigma, Lean, 5S, JJOS or ASQ certification and trainings are an asset Other.
Requires up to 10% domestic travel is anticipated for this position 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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
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