Based in Chicago the Quality Engineer is responsible for providing quality assurance knowledge and hands-on support for all aspects of site new product launches and production operations and ensuring that all site operations remain compliant with all FDA regulations, ISO standards, customer requirements, internal policies and procedures. Under the direction of the Sr. Director of Quality Assurance, the Quality Engineer will be the owner of: quality planning; validations; FMEA and risk analysis; first article inspections; capability studies; Design of Experiment (DOE); developing, reviewing, and/or revising procedures; variance and complaint investigation and resolution; root cause analysis; corrective and preventative actions; and all other areas of quality control programs in a cGMP and ISO 13485 environment. The Quality Engineer will also be responsible for providing quality representation and support in: the ongoing development, evaluation, and improvements of Xeris Pharmaceuticals quality programs and systems; quality assurance testing methodology; internal and external audits; complaint investigations; training initiatives and programs; cross-functional process improvement activities; and any other business initiative requiring quality support.
• Follow and ensure that all personnel comply with FDA regulations, ISO standards, customer requirements, and SOPs as defined by Xeris Pharmaceuticals policies and procedures. • Authorized to represent quality in signing on Engineering Change Orders. • Manage all quality responsibilities for assigned manufacturing changes and new product launches, including but not limited to: developing and executing process validation protocols and publishing reports; develop area, process, and supplier quality plans and out of control action plans; implement Statistical Process Control (SPC) in manufacturing processes where applicable. • Participate in review of manufacturing and testing of new products to ensure quality compliance and that all products meet or exceed customer requirements. • Monitor (by performing machine and process capability and performance studies); recommend improvements (to processes, procedures, systems, and machinery, etc.) to increase quality compliance and/or to meet or improve productivity and specification standards; present improvement plans and obtain management approval; and implement approved improvements; provide any related reports and documentation required for implementation. • Participate in FAT, Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ); draft and/or review protocols and reports; qualify/validate production processes. • Ensure that all documentation is completed in a timely manner and follows established policies, practices, and procedures. • Responsible for customer complaints including: perform investigation, including root-cause analysis, implement contain and corrective action plan, complete documentation of findings, and be the point of communication with customer. • Lead or support by providing quality representation for internal and external audits and customer visits. • Provide training to new or updated manufacturing processes or procedures. • Train Quality and Manufacturing personnel on specifications, inspection and testing activities, new product audits, environmental controls, to ensure understanding and compliance to procedures and policies; request training, training support, and/or re-training as needed. • Support MRB evaluations, as required. • Ensure part and/or product compliance to specification by performing independent inspection of components and finished goods, provide feedback and implement improvements to inspection process and testing procedures to increase quality compliance. • Provide quality support and representation for cross-functional initiatives and projects. • Utilize lean manufacturing root cause analysis/problem solving methods to identify opportunities to increase safety and quality compliance and to reduce cost, lead time, inventory, and defects. • Lead or support Design Control activities.
• Bachelors’ degree in engineering or equivalent experience. • 3+ years of work experience in a Quality Engineering role or equivalent experience. • Experience in contract manufacturing and/or manufacturing environment preferred but not required. • Experience working in a regulated environment (ISO 13485, 21 CFR Part 4, 21 CFR 820 , 21 CFR 210, 211 or other) preferred but not required. • Experience in combination products, pharmaceutical and device manufacturing preferred but not required. • Injection molding experience preferred but not required. • Experience in Device Software development and validation preferred. • Advanced computer capabilities including all MS Office products. • Strong interpersonal, written, and oral communication skills. • Well organized; and able to multi-task, prioritize and manage multiple deliverables while working in a fast-pace environment. • Problem-solving skills and critical thinking. • Highly motivated, focused, self-starter. • Quality driven customer service. • Able to work individually and as part of a team. • Knowledge and familiarity with Optical Gauging Product (OGP), Coordinate Measuring Machine (CMM), other mechanical measurement equipment (indicators, micrometers, etc.), and other measuring devices used to ensure quality and acceptability of product. • Able to read and interpret blueprints. • Familiar with Geometric Dimension & Tolerance (GDT) procedures and requirements. • Knowledge of statistical techniques (design of experiments, measurement R&R, statistical process control) preferred but not required. • Working knowledge and experience with quality management software. • Knowledge of FDA QSR, ISO 13485, Quality Risk, and ISO 14971 Risk Assessment preferred but not required.
Internal Number: 002
About Xeris Pharmaceuticals
Xeris is a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use, liquid-stable injectables. The company’s proprietary XeriSol™ and XeriJect™ formulation technologies allow for the subcutaneous (SC) and intramuscular (IM) delivery of highly concentrated, non-aqueous, ready-to-use formulations of peptides, proteins, antibodies, and small molecules using syringes, auto-injectors, multi-dose pens, and infusion pumps. Xeris’ platforms have the potential to offer distinct advantages over existing formulations of marketed and development-stage products. In particular, XeriSol™ and XeriJect™ offer the opportunity to eliminate reconstitution, enable long-term room temperature stability, significantly reduce injection volume, and eliminate the requirement for intravenous (IV) infusion. These attributes can lead to products that are easier to use by patients, caregivers, and health practitioners and reduce costs for payers and the healthcare system