Quality Engineer

About the role

Position Summary: We are seeking a Test Method Validation Engineer to support validation activities within a regulated manufacturing environment. This role is responsible for planning, executing, and documenting Test Method Validation (TMV), and validation remediation efforts. The engineer will partner closely with Engineering, Quality, Manufacturing, Operations, and R&D teams to ensure processes and test methods consistently meet product quality, regulatory, and business requirements. The ideal candidate has experience executing validation protocols, performing statistical analysis, troubleshooting validation issues, and driving remediation activities to completion. Experience in the medical device industry and knowledge of quality-system requirements are preferred. Knowledgeable use of Minitab and experience remediating validation documents are a plus. Located in Twin Cities, Minnesota.

Responsibilities

• Validation Execution: Lead and execute Test Method Validation (TMV) activities; develop, review, and support approval of validation protocols and reports, including TMV; plan and perform validation testing, including sample preparation, test method execution, and data collection; analyze validation results and document findings, deviations, and corrective actions; support equipment, process, and test method qualification activities.
• Validation Remediation: Lead validation remediation projects to address gaps in historical validation documentation and align records with current quality-system requirements; review existing validation records and determine appropriate remediation strategies; develop remediation plans, protocols, reports, and supporting documentation; track remediation activities, schedules, risks, and deliverables through successful completion.
• Statistical Analysis and Problem Solving: Perform statistical analysis to support validation conclusions; apply statistical methods such as Gage R&R, Measurement System Analysis (MSA), process capability analysis, and Design of Experiments (DOE); interpret data and provide clear technical recommendations; investigate validation-related issues and collaborate with cross-functional teams to implement effective solutions.
• Cross-Functional Collaboration: Partner with Engineering, Quality, Manufacturing, Service and Training teams to complete validation activities; support operator training for execution of validation activities; participate in risk assessments and continuous improvement initiatives.
• Documentation and Compliance: Maintain complete and accurate validation records in accordance with applicable quality system and regulatory requirements; author and review validation plans, protocols, reports, risk assessments, engineering studies, and supporting documentation; support compliance with applicable FDA requirements, ISO 13485, and internal procedures.

Requirements

• Bachelor's degree in Engineering or a related technical field.
• 5+ years executing TMV activities.
• Knowledge of the complete validation lifecycle, including protocol development, execution, data analysis, deviation management, and final reporting.
• Experience working in a regulated manufacturing environment; medical device experience preferred.
• Strong technical writing and documentation skills.
• Ability to independently manage multiple validation activities and meet established timelines.
• Strong analytical, organizational, problem-solving, and communication skills.

Qualifications

• Experience with medical device manufacturing processes.
• Knowledge of DOE, MSA, and process capability analysis.
• Knowledgeable in the use of Minitab statistical software.
• Experience remediating validation documents, including legacy validation records, is a plus.
• Lean Six Sigma certification or practical continuous improvement experience.
• Experience supporting audits and regulatory inspections.