Quality Engineer

Position SummaryThe Quality Engineer is responsible for independently driving quality assurance activities that support the design and stability of compliant manufacturing processes. This role ensures robust product and process quality throughout the entire product lifecycle, with a particular focus on process validation (IQ/OQ/PQ), test method validation (TMV), and owning the investigation, root cause analysis, and final resolution of Nonconformances (NCMs) and Corrective and Preventive Actions (CAPAs). This Engineer works collaboratively with Production, Engineering, and various cross-functional teams to deploy quality initiatives that enhance consistent process execution, improve operational efficiency, and maximize product reliability. This position requires a solid, applied understanding of quality management systems and industry regulations to ensure manufacturing readiness, support data-driven decision making, and champion continuous improvement efforts.Core ResponsibilitiesIndependently manage the review and formal approval of essential quality records, change controls, and production batch documentation, confirming adherence to both internal protocols and external regulatory standards.Direct the execution of qualification activities, including Installation, Operational, and Performance Qualifications (IQ/OQ/PQ), Test Method Validation (TMV), and Gage Repeatability and Reproducibility (Gage R&R) studies, ensuring protocols are followed precisely and reliable data is captured.Own and lead the entire Nonconformance Management (NCM) lifecycle. This includes conducting initial disposition reviews, defining appropriate containment actions for nonconforming material and product, and ensuring timely documentation.Manage the Corrective and Preventive Action (CAPA) process from initiation through closure. This involves defining and documenting robust corrective and preventive actions, overseeing implementation, and providing technical justification.Lead comprehensive root cause analysis (RCA) for nonconformances and critical quality issues using structured methodologies (e.g., 5 Whys, Fishbone, 8D), ensuring solutions address the systemic cause.Utilize advanced statistical tools (such as control charts, capability analysis, and t-tests) to analyze key process data and support risk-based decisions concerning process capability and enhancement projects.Lead risk assessments and oversee the development or necessary updates of Process Failure Mode and Effects Analysis (PFMEA) documents, coordinating input from engineering, operations, and regulatory teams.Generate or update inspection plans, detailed manufacturing procedures, and test methodologies to guarantee appropriate quality coverage and effective risk mitigation across all product lines.Support and represent the quality function during both internal and external regulatory inspections, ensuring consistent demonstration of compliance with documented procedures.Execute necessary sampling plans and perform measurement system evaluations to ensure the reliability of all inspection data and production readiness.Review and evaluate documentation provided by suppliers regarding material quality; participate in supplier performance assessments and support timely resolution of incoming material discrepancies.Lead or significantly contribute to structured problem-solving and continuous improvement projects, including independently verifying the long-term effectiveness of implemented CAPA solutions.Provide expert quality guidance for specific assigned product lines or operational processes, including support during engineering design changes, managing deviations, and resolving complex technical issues.Review and formally assess the quality impact of proposed process or equipment modifications, contributing essential technical justifications and necessary change control documentation.Clearly communicate quality risks, investigation findings, and critical quality metrics to team leaders, cross-functional partners, and executive management.Education and Experience RequirementsBachelor’s degree in Engineering (Mechanical, Electrical, or Industrial), Science, or a closely related technical field.1–3 years of hands-on experience in quality or manufacturing engineering within a regulated environment (e.g., medical device, pharmaceutical).Specialized Skills / Other RequirementsApplied knowledge of recognized quality standards such as ISO 13485 and US regulations like 21 CFR Part 820, along with internal Quality Management System (QMS) standards.Proficiency with essential quality tools, including Root Cause Analysis (RCA) methodologies, FMEA, Gage R&R, and fundamental Design of Experiments (DOE).Demonstrated basic understanding of manufacturing controls and the full process validation lifecycle.Ability to execute tasks independently and actively participate in collaborative, cross-functional team initiatives.Proficient in Microsoft Office suite; proven experience utilizing statistical analysis tools (e.g., Minitab, JMP) is a strong plus.Familiarity with continuous improvement principles (Structured Problem Solving, Lean, Six Sigma).Possesses strong organizational skills and exceptional attention to detail.