Senior Manufacturing Quality Engineer

Position Summary  The Senior Manufacturing Quality Engineer is a technical leader responsible for ensuring manufacturing processes consistently produce safe, effective, and high-quality medical devices. This individual partners closely with Manufacturing Engineering, Process Engineering, R&D, Operations, Supply Chain, and Regulatory Affairs to develop, validate, monitor, and continuously improve manufacturing processes from development through commercialization and sustained production. This role requires deep expertise in process characterization, statistical engineering, validation, and continuous improvement within a regulated medical device environment.
Position Summary  The Senior Manufacturing Quality Engineer is a technical leader responsible for ensuring manufacturing processes consistently produce safe, effective, and high-quality medical devices. This individual partners closely with Manufacturing Engineering, Process Engineering, R&D, Operations, Supply Chain, and Regulatory Affairs to develop, validate, monitor, and continuously improve manufacturing processes from development through commercialization and sustained production. This role requires deep expertise in process characterization, statistical engineering, validation, and continuous improvement within a regulated medical device environment.

Key Responsibilities   Lead manufacturing quality activities supporting new product introduction (NPI), commercialization, and sustaining manufacturing.
Partner with Manufacturing Engineering during equipment design, process development, automation, and design transfer.
Develop and execute manufacturing quality strategies that ensure robust, scalable, and compliant manufacturing processes.
Ensure compliance with FDA QMSR, ISO 13485, ISO 14971, and internal Quality Management System requirements.
Process Characterization & Validation   Lead process characterization studies to establish critical process parameters and operating windows.
Author, execute, and approve IQ, OQ, PQ, PPQ, equipment qualification, process validation, and revalidation protocols.
Perform process capability studies and statistical analysis to support validation conclusions.
Prepare comprehensive validation reports and technical documentation.
Statistical Engineering   Serve as the manufacturing statistical expert applying DOE, SPC, Cp/Cpk/Ppk, ANOVA, regression analysis, confidence intervals, and statistical sampling.
Analyze manufacturing data using Minitab (required) and JMP (preferred).
Develop control charts, capability analyses, and data-driven recommendations to improve process performance.
Test Method Development & Validation   Develop, optimize, and validate inspection and test methods.
Lead Test Method Validation activities.
Perform Gage R&R, Measurement System Analysis (MSA), and Attribute Agreement Analysis.
Manufacturing Process Improvement   Drive yield improvement, scrap reduction, defect reduction, and process optimization initiatives.
Develop and maintain PFMEAs, Control Plans, Inspection Plans, Sampling Plans, and Process Monitoring Plans.
Lead manufacturing investigations, root cause analysis, CAPAs, and corrective actions using structured problem-solving methodologies.
Cross-Functional Leadership   Work closely with Manufacturing Engineering, Process Engineering, Operations, R&D, Supply Chain, Regulatory Affairs, Quality Systems, and suppliers.
Provide technical leadership during pilot builds, engineering builds, process transfers, and commercial scale-up.
Qualifications   Bachelor's degree in Mechanical, Biomedical, Manufacturing, Chemical, Industrial Engineering, or related engineering discipline.
Minimum 10 years of Quality Engineering experience in the medical device industry.
Minimum 7 years supporting manufacturing operations and process validation.
Demonstrated expertise in automated manufacturing, process characterization, statistical analysis, and commercialization.
ASQ Certified Quality Engineer (CQE) preferred.
Lean Six Sigma Green Belt or Black Belt preferred.
Required Technical Expertise   Process Characterization, IQ/OQ/PQ, PPQ, Equipment Qualification, Process Validation, Revalidation.
DOE, SPC,…