(Sr.) Manufacturing Quality Engineer

<p><span>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</span></p><p></p><p></p><p><b><span><span>Job Function: </span></span></b></p>Supply Chain Engineering<p></p><p></p><p><b><span><span>Job Sub </span></span><span><span>Function: </span></span></b></p>Quality Engineering<p></p><p></p><p><b>Job Category:</b></p><span>Scientific/Technology</span><p></p><p></p><p><b>All Job Posting Locations:</b></p>Aachen, North Rhine-Westphalia, Germany<p></p><p></p><p><b>Job Description:</b></p><p>At Abiomed, part of Johnson &amp; Johnson, we are currently seeking a highly skilled and motivated individual to join our team as a (Sr.) Manufacturing Quality Engineer. In this role, you will have the unique opportunity to contribute to manufacturing of life-saving medical devices. As part of our "Patients First!" culture, you will play a crucial role in ensuring the highest quality standards are met to save lives and recover hearts.</p><p></p><p>This position can be either a specialist or senior specialist level, based on level of experience and qualifications.</p><p></p><h2><span>Responsibilities and Duties:</span></h2><ul><li><p>Provide quality engineering support in the development and manufacturing of new and existing medical devices.</p></li><li><p>Ensure compliance of manufacturing processes and areas to all applicable quality system regulations.</p></li><li><p>Lead Quality reporting such as, key performance metrics, goals, and objectives.</p></li><li><p>Lead and support activities related to the Material Review Board.</p></li><li><p>Lead non-conformance investigations, including cause analysis, documenting findings, and approving material dispositions. Promptly address any quality concerns through corrections, <span>corrective/preventative</span> actions, and Escalations.</p></li><li><p>Monitor and analyze production information to support risk management and provide direction for corrective and preventive actions (CAPA) and/or process improvement activities.</p></li><li><p>Validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), Test method validations (TMV).</p></li><li><p>Collaborate with manufacturing engineering to ensure the implementation of necessary process controls and validations, while adhering to established guidelines (GMP).</p></li><li><p>Support process optimization using design of experiments (DOE) and retrospective data analysis to understand and minimize sources of process variation affecting products. Identify key process input variables and key process output variables.</p></li><li><p>Support Quality Management System (process development, creating and editing new and existing SOPs). Support internal and external auditing requirements in manufacturing.</p></li></ul><p></p><h2><span>Qualifications:</span></h2><ul><li><p>A Bachelor's degree in a relevant Engineering /Applied Science/ or equivalent field is necessary.</p></li><li><p>6+ years of experience in QA/QE in the medical device field is preferred</p></li><li><p>Experience with manufacturing of complex products in environmentally controlled area, catheter-based or cardiac assist devices preferred. Equivalent experience in the manufacturing of highly regulated products will also be considered.</p></li><li><p>Experience with formal problem-solving methodologies, risk management (e.g.: FMEAs) and deductive skills.</p></li><li><p>Good understanding of FDA QSRs, ISO13485, ISO14971.</p></li><li><p>Experience with handling non-conforming material and assemblies, including root cause investigations.</p></li><li><p>Experienced in qualification of production equipment and validation of production processes.</p></li><li><p>Drives accountability for quality compliance and champion a proactive quality, compliance and risk based driven culture</p></li><li><p><span>Provides leadership to assure day-to-day decisions are well supported and documented</span></p></li><li><p><span>Leads site/global projects striving to simplify / streamline processes across the organization, eliminate redundancies and further improve compliance in a changing healthcare environment.</span></p></li><li><p><span>Comfortable in collaborating in cross-functional and multi-cultural teams</span></p></li><li><p><span>Advanced in German and English is required </span></p></li></ul><p></p><p><span>The anticipated base pay range for a senior specialist position is 75,000 to </span><span>118,450 Eu