Senior Quality Engineer

<p style="text-align:left !important">At Johnson &amp; 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 <a target="_blank" href="https://www.jnj.com."><span style="color:#0000ff"><u>jnj.com</u></span></a>.</p><p></p><p>As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.</p><p></p><p></p><p style="text-align:left"><b><span><span>Job Function: </span></span></b></p>Quality<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span><span>Job Sub </span></span><span><span>Function: </span></span></b></p>Quality Assurance<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Category:</b></p>Professional<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>All Job Posting Locations:</b></p>Ciudad Juarez, Chihuahua, Mexico, Ciudad Juarez, Mexico<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Description:</b></p><p>At Johnson &amp; 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.jnj.com/.</p><p></p><p><b>We are searching for the best talent for Senior Quality Engineer to be in Juarez, Salvarcar, Plant. </b></p><p></p><p><b>Purpose: </b> Participate in new product/process teams to develop quality-engineered systems and</p><p>products, lead and support design verification tests, process validations, quality</p><p>processes to ensure compliance with the company’s Quality System policies and</p><p>procedures and applicable external requirements and standards, including FDA, ISO</p><p>13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson &amp; Johnson</p><p>Environmental, Health &amp; Safety Practices, and other applicable standards as pertains to</p><p>medical devices. Drive quality assurance activities intended to ensure effective product</p><p>quality processes are in place and executed throughout lifecycle of product. May receive</p><p>technical guidance on complex problems, but independently determines and develops</p><p>approaches and solutions. Shares technical expertise with others and helps develop</p><p>junior level engineers.</p><p></p><p><b>You will be responsible for:</b></p><p>Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson &amp; Johnson, procedures and guidelines, this position:</p><ul><li><p>In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson &amp; Johnson, procedures and guidelines, this position:</p><p>• Primary responsibilities include working in Quality Engineering and with other functional groups in support of new product/process development, quality operations or quality assurance.</p><p>• Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.</p><p>• Leading efforts with quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction.</p><p>• Develop and establish effective quality control and support associated risk management plans.</p><p>• Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.</p><p>• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).</p><p>• Determine sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products.</p></li></ul><p></p><p>Qualifications:</p><ul><li><p>Bachelor’s degree in a related field, or research and development experience in a medical device or other regulated industry is required.</p></li><li><p>4 to 6 years of work experience or demonstrated performance.</p></li><li><p>American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.</p></li><li><p>Knowledge of GD&amp;T (Geometric Dimensioning and Tolerancing) is desirable</p></li><li><p>Ability to develop and implement Quality standards.</p></li><li><p>Thorough knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices.</p></li><li><p>Thorough knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&amp;V) tools and methodologies.</p></li></ul><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p> </p><p> </p><p><b>Required Skills: </b></p><p> </p><p> </p><p><b>Preferred Skills:</b></p>Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control (QC), Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy