Quality Engineer

Medical Engineering Consultants (MEC); Twin Lakes (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Medical Engineering Consultants (MEC) is seeking a Test Method Validation Engineer to lead TMV activities in a regulated manufacturing setting. You will plan, execute, and document TMV, and partner with Engineering, Quality, Manufacturing, Operations, and R&D to ensure methods meet quality, regulatory, and business requirements.

The ideal candidate has 5+ years of TMV experience in a medical device environment, strong technical writing skills, proficiency in Minitab, and a track record of

Qualifications

• Bachelor's degree in Engineering or a related technical field.
• 5+ years executing TMV activities.
• Experience in a regulated manufacturing environment; medical device preferred.
• Strong writing and documentation skills.

Responsibilities

• Lead and execute TMV activities with documented results.
• Develop and review validation plans, protocols, and reports.
• Plan validation testing, data collection, and analysis.
• Remediate historical validation records to meet current requirements.
• Collaborate with cross-functional teams on risk assessments and improvements.

Skills

TMV execution

Statistical analysis

Technical writing

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Engineering or related field

Tools

Minitab

Job description

Job 2983 - Quality Engineer - Contract located in Twin Cities, Minnesota

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

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.

Key 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.

Required Qualifications

• 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.

Preferred 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.

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

• Sponsorship is not available for this position.

Check us out at www.medicalengineeringconsultants.com

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.