Senior Quality Engineer, Design Quality

<p> </p> <p>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?  </p> <p> </p> <p>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.  </p> <p> </p> <p>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.  </p> <h4><b>Job Summary</b></h4> <p>Reporting to the Design &amp; Quality Assurance Director, the job holder will be the QA lead supporting West proprietary design &amp; development projects (in Elastomer &amp; Primary Containment) with key focus and responsibility around the interpretation, application of and compliance to relevant standards, regulations and internal procedures. The Senior Quality Engineering Specialist will manage the quality aspects of West proprietary design &amp; development projects; will provide West proprietary design &amp; development teams with guidance on design quality-related issues and design control best practices; and drive a culture of compliance and continuous improvement within West proprietary design &amp; development teams. </p><h2><b>Essential Duties and Responsibilities</b></h2> <ul> <li>Program Activities:</li> <li> <ul type="disc"> <li>Responsible for ensuring proprietary design &amp; development projects are executed in compliance with relevant regulations; regulatory requirements; international standards; and enterprise and local procedures.</li> <li>Identify and support the use of improved quality practices by R&amp;D teams during design control activities; and facilitate the smooth integration of quality requirements into design processes.</li> <li>Report on the progress of projects; identify successes; and drive compliance.</li> <li>Escalate quality-related issues to the Design &amp; Quality Assurance Director or designee, as required.</li> <li>Review and approve relevant design history file documents; product drawings; component specifications; labelling; procedures.</li> <li>Support design transfer activities for commercial and launch readiness and sustainment.</li> </ul> </li> <li>Verification and Validation Activities: <ul type="disc"> <li>Review and approve test method validations (protocols and reports).</li> <li>Review and approve design verification and design / process validation documents (e.g. protocols &amp; technical reports).</li> <li>Facilitate and support the completion of projects up to and including PQ.</li> </ul> </li> <li>Risk Management Activities: <ul type="disc"> <li>Responsible for authoring and/or reviewing and approving Risk Management Plans, risk assessments and Risk Management Summary Reports for proprietary design &amp; development projects.</li> <li>Facilitate and/or participate in risk assessment meetings with proprietary design &amp; development teams.</li> </ul> </li> <li>QMS Activities: <ul type="disc"> <li>Support enterprise procedures updates that impact design and development activities.</li> <li>Drive the closure of change controls and protocol non-conformance reports (PNRs).</li> <li>Review and draft relevant procedures and forms for the management of activities connected with product design &amp; development. </li> <li>Act as the interface between development teams and operational quality:</li> <li>Perform first article component and product inspections</li> <li>Draft defect libraries and quality inspection documents during OQ; and manage formal hand over of same to Operational Quality prior to PQ.</li> <li>Support the supplier selection process in accordance with West supplier management procedures.</li> <li>Conduct and support internal and supplier audits, as required.</li> <li>Lead internal audits of R&amp;D and support site QA in the preparation and hosting of third party and customer audits.</li> <li>Lead and manage QMS activities including CAPAs, Failure Investigations, Non-Conformance assessments, audit findings, issue reviews, document control, change controls, and configuration management. Provide direction on non-conformances, deviations, or excursions and drive to closure.</li> <li>Actively engage in robust problem-solving to address quality issues. </li> </ul> </li> <li>Metrology Activities: <ul type="disc"> <li>Review and approve metrology data during OQ &amp;