Senior Specialist, QA

<p><span><span><b>Who We Are:</b></span></span></p> <p> </p> <p><span><span>At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  </span></span></p> <p> </p> <p><span><span>There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  </span></span></p> <p> </p> <p><span><span>We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  </span></span></p> <p> </p> <p><span><span><b>Job Summary:</b></span></span></p> <p> </p> <p><span><span>The Senior Associate, Quality Assurance oversees projects, maintains processes and addresses quality issues by analyzing outcomes and collaborating with teams for effective resolutions.  This position will continue the QA routine activities of a working WSS lab and QA duties for future business.</span></span></p> <p> </p> <p><span><span><b>Essential Duties and Responsibilities</b></span></span></p> <p> </p> <ul> <li><span><span>Contribute to the development and implementation of quality management programs focusing on continual improvement across various processes.</span></span></li> <li><span><span>Create processes to better evaluate, track and trend audit outputs and identify risks/issues and evaluate impact on global quality systems and initiate actions, as needed.</span></span></li> <li><span><span>Independently performs supplier audits and corporate facility audits.</span></span></li> <li><span><span>Manage multiple project tasks and effectively coordinate handling of customer feedback and complaints.</span></span></li> <li><span><span>Lead assessment and closure of customer complaints, ensuring adherence to established procedures and documentation.</span></span></li> <li><span><span>Lead the evaluation and resolution of customer complaints, ensuring adherence to prescribed procedures and comprehensive documentation.</span></span></li> <li><span><span>Coordinate communication between internal teams and customers</span></span></li> <li><span><span>Regularly analyze data trends, drive improvements and meet customer expectations through efficient reporting and communication</span></span></li> <li><span><span>Reviews, revises, and creates operating procedures to ensure compliance with all related external requirements, internal procedures or instructions, and the West Quality Manual.</span></span></li> <li><span><span>Ability to lead meetings with customers, employees and contractors as necessary to manage changes.</span></span></li> <li><span><span>Establishes monthly KPI’s and metrics to Quality Leadership.</span></span></li> <li><span><span>Drive continuous quality improvement projects across the enterprise for increased compliance and to create efficient use of company resources</span></span></li> </ul> <p> </p> <p><span><span><b>Education:</b></span></span></p> <ul> <li><span><span>Bachelor's Degree In Engineering or Science - required</span></span></li> <li><span><span>Master's Degree In Engineering or Science - preferred           </span></span></li> </ul> <p><span><span><b>Work Experience:</b></span></span></p> <p> </p> <ul> <li><span><span>Minimum 5 years of experience as Sr Associate is required</span></span></li> </ul> <ul> <li><span><span>Experience in regulated Quality Assurance / Document/Configuration Control (or a formal education equivalent)</span></span></li> <li><span><span>Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities</span></span></li> <li><span><span>Experience with quality systems such as ISO 9001, ISO 15378 and ISO 13485, 21 CFR 820</span></span></li> <li><span><span>Experience Leading Internal / External Audits, MasterControl, SAP and Share Point</span></span></li> <li><span><span>Experience with customer interface and meeting customer expectations.</span></span></li> </ul> <p> </p> <p><span><span><b>Preferred Knowledge, Skills and Abilities:</b></span></span></p> <p> </p> <ul> <li><span><span>Ability to work independently, multi-task and thrive in fast-paced environment.</span></span></li> <li><span><span>Excellent written and verbal communication skills</span></span></li> <li><span><span>Proficient in statistical soft