<p>Overview</p> <p>We are seeking an experienced Quality Engineer II that will actively participate in the Repligen ISO 9001:2015 Quality Management System. This role is responsible for providing Quality Engineering support for new product development, manufacturing transfer activities and supporting manufacturing for commercial products.</p> <p>Responsibilities</p> <ul> <li>Must be familiar with Validation Principles and Concepts, Design Controls Processes in accordance with regulatory requirements (e.g., Quality ISO standards, ASME BPE, CE, BPOG, REACH, etc.). </li><li>Supports the New Product Introduction (NPI) team with deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. Work with multi-functional product development teams to help verify new product development deliverables and compile product Design History Files to support product release. </li><li>Experience in areas of Design Controls & Risk Management to cross-functional teams responsible for new product development or design changes. Product line support will focus on hardware devices and associated consumables used for biotech products. </li><li>Supports the comprehensive completion of risk management (FMEA), Design and Process Verification activities for products and processes. </li><li>Assists in the development and validation of appropriate test methods for product and process performance. </li><li>Review of Equipment IOPQ's in support of commercial operations. </li><li>Strong organization skills with the ability to effectively muti-talk and prioritize </li><li>Self-motivated with sound judgment and problem-solving skills. </li><li>Assists with customer complaint investigations when required </li><li>Effective in executing change controls and running change control review board meetings. </li><li>Review and approval of nonconformances, deviations, failure investigations and corrective action plans prior to implementation when required. </li><li>Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal results </li></ul> <p>Qualifications</p> <ul> <li>BA/BS degree (in a Biological Science, Engineering, or Physical Science required). </li><li>Must have prior experience in New Product Development Quality Engineering. </li><li>Experience with biotech hardware and consumable products and associated manufacturing processes. </li><li>Basic understanding of cell culture and filtration and chromatography operations in a bioprocess setting is required for this position. </li><li>Certified Quality Engineer (ASQ CQE, CRE or equivalent) preferred. </li><li>Minimum of 3-5 years' experience as a Quality Engineer in an ISO 9001 Quality Management System or equivalent. </li><li>Internal Auditing. </li></ul>