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Johnson & Johnson is recruiting for a Senior Commercial Quality Engineer , located in Mooresville, IN.

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

This individual will be accountable for 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 Medical Device Distribution Center Mooresville in the United States.

Senior Commercial Quality Engineer is responsible for supporting quality and compliance activities at the MedTech Distribution Center in Mooresville. IN, including validation activities, new product introduction, participating in NC/CAPA investigations, and performing audit activities. Senior Commercial Quality Engineer will report to the Sr. Commercial Quality Manager in Mooresville, IN.

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 Commercial Quality business objectives
• Works as Quality liaison between J&J business and 3PL site for introduction of new products
• 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
• Provide quality support for quarantine product process
• Coach and mentor other functional areas in the areas of CFR, ISO and cGMP requirements as needed
• Provides specific technical expertise to support special projects, product/process improvements and provides input to support business needs for temperature sensitive products and other opportunities
• Identifies and implements potential cost savings and project execution improvements
• Review Deliver metrics data for management review

Qualifications

Education:

University/Bachelors of Arts degree in Arts or Bachelors of Science degree in an Engineering, Scientific, Technical Scientific, or Quality Regulatory Compliance discipline or equivalent

Experience and Skills

Required:

• Four to six (4-6) years of related work experience
• Prior experience in a quality engineering role and experience working with an indirect organization that delivers results
• 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 communication skills, and strong collaboration and influence skills to partner effectively across functions and operating units

Preferred:

• Six Sigma, Lean, 5S, JJOS or ASQ certification and trainings are an asset
• Makes the complex clear and easily understood by others
• Flexible with ability to work independently and on teams, has excellent time management skills to handle multiple projects and deadlines
• Strong knowledge of FDA 21 CFR Part 820 and ISO 13485 or MDSAP and WMS, ERP systems

Other:

• 10% Travel domestically
• Perform other related duties as required
• Works independently on routine and non-routine task
• Serves as subject matter expert within functional area
• Thinks analytically and acts decisively

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.