Quality Engineer II
2 days ago
The Quality Engineer 2, Manufacturing independently executes quality engineering activities that support the development and maintenance of compliant manufacturing processes. This role contributes to product and process quality throughout the product lifecycle, with emphasis on process validation, test method validation, regulatory compliance, and quality system support. The QE2 works collaboratively with manufacturing, engineering, and cross-functional partners to implement quality initiatives that promote consistent process execution, operational efficiency, and product reliability. The QE2 applies working knowledge of quality systems and industry regulations to support manufacturing readiness, risk-based decision making, and continuous improvement.
Independently review and approve quality records, change controls, and production documentation to ensure compliance with internal procedures and regulatory standards. Lead the execution of validation activities (IQ/OQ/PQ), test method validation (TMV), and Gage R&R studies by ensuring adherence to protocols and proper data collection. Use statistical tools (e.g., control charts, capability analysis, t-tests) to analyze process data and support decision-making related to process capability and improvement. Lead risk assessments and drive PFMEA development or updates in coordination with engineering, manufacturing, and regulatory teams. Own nonconformance investigations, perform root cause analysis, and support timely and effective CAPA development and closure. Author or revise inspection plans, manufacturing procedures, and test methods to ensure appropriate inspection coverage and risk mitigation. Support and represent the quality function during internal audits and regulatory inspections by demonstrating compliance with documented processes. Independently execute sampling plans and conduct measurement system evaluations to ensure data reliability and inspection readiness. Review and assess supplier quality documentation; participate in supplier evaluations and support resolution of incoming material issues. Lead or contribute significantly to structured problem-solving and continuous improvement initiatives within the quality or operations function. Provide quality guidance for assigned product lines or processes, including support during engineering changes, deviation management, or issue resolution. Review and assess quality impact of process or equipment changes and contribute to technical justifications and change control documentation. Communicate quality risks, investigation results, and quality metrics effectively to team leaders, cross-functional stakeholders, and management.
Bachelor's degree in engineering, science, or related field. 13 years of experience in quality or manufacturing engineering in a regulated environment.
Working knowledge of ISO 13485, 21 CFR 820, and internal QMS standards. Proficiency in core quality tools (FMEA, Gage R&R, basic DOE). Basic understanding of manufacturing controls and process validation. Ability to execute tasks independently and participate in cross-functional initiatives. Proficient in Microsoft Office; experience with statistical tools preferred. Familiar with continuous improvement principles (Lean, Six Sigma). Strong organizational skills and attention to detail.
TRAVEL REQUIRED: 10%
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