Quality Engineer LGC Clinical Diagnostics team develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC's products to support accurate and reliable diagnostic results. Our operating entities include Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and the Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 400+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), and an ISO 9001-accredited facility in Oxford, UK. Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics. Job Purpose The Quality Engineer is responsible for reviewing, analyzing, and improving quality management systems, production processes, and overall product use and service experiences for SeraCare customers by identifying, evaluating, communicating, and controlling explicit and implicit requirements. Reporting to site lead for Quality Assurance, this role requires sound quality engineering practices for problem solving, risk assessment, and overall change control to achieve the goal of consistent, high quality products through efficient, controlled processes. Key activities for this role are centered around sustaining production support as well as design control activities for new product development. Specific tasks include oversight of verification and validation activities, data analysis and trending, root cause investigation and corrective action, and change management as well as review and release of batch and raw material records. Key Responsibilities Manage site validation activities encompassing equipment qualification, and software and process validations. Maintain Validation Master Plans. Provide support during product and process validations by guiding the team through IQ, OQ, and PQ stages of the validation process. Review, approve, author, and execute validation protocols and reports. Manage site change order process to assess and appropriately document risk including impact to internal and customer-related processes. Coordinate with functional teams across multiple sites to ensure timely completion of change activities. Work with Manufacturing Operations, QC, and Technical Support to evaluate production processes and monitor product quality performance. Collaboratively solve manufacturing and quality issues. Investigate quality issues and trends from customer complaints, NCMRs, CAPAs, etc. to identify actions required. Participate in and lead teams during the investigation of root cause, quality problems, and complaints using statistical techniques (DOE, ANOVA, Regression, Analysis, etc.). Implement appropriate and efficient corrective actions to avoid problems and/or prevent recurrence. Review and approve Document Change Requests (DCRs) related to materials, production processes, test methods, and quality plans as required. Oversee risk management documentation with deliverables including risk plans, risk assessments (design and process FMEAs), and risk reports. Review risk control actions for completeness, feasibility and adequacy. Track mitigation efforts to reduce medium and high risks to acceptable levels. Identify improvements to reduce scrap, rework, complaints, and other sources of Cost of Poor Quality (COPQ) in line with quality and cost reduction initiatives. Initiate SOP changes to streamline, standardize, and improve quality system processes. Support large-scale projects such as electronic systems implementation and integration. Support ongoing product release activities such as review of raw material receipts, batch records, QC results, and environmental monitoring records. Assess excursions with appropriate deviations and/or risk evaluations. Work with Facilities to evaluate equipment performance requirements and management of calibration, preventive maintenance, and unscheduled repair activities. Review controlled space monitoring reports and evaluate Out of Tolerance (OOT) and repair events for impact to product quality. Support product stability studies through careful review of challenge conditions and requirements. Perform internal and supplier audits, issue audit reports, and follow up to close out actions which address the findings. Provide training and support for quality concepts and tools. Knowledge, Experience and Technical Skills Ability to interpret FDA QSR regulations as well as ISO 13485 and ISO 14971 Comprehensive validation experience including ability to guide prospective, concurrent, and retrospective studies Knowledge of statistical methodologies, quality control and manufacturing operations Ability to strategically evaluate and implement practical, timely resolution of non-conformances, deviations, customer complaints, and CAPAs Intermediate to advanced computer skills with word-processing systems, spreadsheets, databases, ERP systems, and electronic quality management system software Strong interpersonal, organizational, verbal and written communication skills Demonstrates curiosity, adaptability and commitment; works best in a team environment and actively seeks to foster relationships Focused on problem solving including problem definition, risk evaluation, and risk-based resolution Ability to ask probing questions to understand unstated expectations and underlying issues, understand competing priorities, and facilitate discussions to gain consensus through the problem-solving process Oriented for continuous improvement with desire to always balance the level of control and flexibility in systems based on risk Strong analytical and examination capabilities for complex projects; ability to develop process maps, organize data, evaluate options, document plans, and communicate progress. Strong attention to detail Performance driven with ability to work positively and collaboratively with cross-functional teams Ability to manage multiple tasks and meet timelines with minimal supervision Education and/or Experience Bachelor's Degree in a scientific discipline with experience in quality engineering 5 + years' experience working in a cGMP or ISO 13485 environment Experience with Lean and/or Six Sigma concepts highly desired Physical Demands Requires prolonged sitting and standing and the use of equipment and computers. Repetitive motion using a keyboard for long periods of time. May be required to lift and move material weighing up to 25 lbs. Work Environment Agreeable work environment typical of an operations setting with some exposure to noise from equipment and office machines. This is an onsite position that will require daily attendance to the Gaithersburg location.