Quality Engineer

Prentke Romich GmbH

. Support quality systems, regulatory compliance activities, and continuous improvement initiatives .

Posted 10/9/2026full-timeWooster • Ohio • United StatesMid-LevelSenior💰 $60,000 - $75,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in quality systems, regulatory compliance, and continuous improvement methodologies, with a strong foundation in quality engineering principles and statistical methods. Proficient in root cause analysis and capable of developing inspection plans and validation activities to ensure product conformity in regulated environments.

Highest-signal resume keywords

Quality Engineering PrinciplesRoot Cause AnalysisStatistical MethodsRegulatory ComplianceContinuous Improvement Tools

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Root Cause AnalysisFMEAControl ChartsDMAICPDCA5SKaizenData AnalysisTesting and ValidationQuality Procedures Development

Soft Skills

Problem-SolvingDecision-MakingAttention to DetailVerbal CommunicationWritten Communication

Tools & Technologies

Microsoft OfficeElectronic Test Equipment

Industry Keywords

Medical DevicePharmaceuticalBiotechFoodAerospaceAutomotive

About the role

Key responsibilities & impact

Support quality systems, regulatory compliance activities, and continuous improvement initiatives
Develop and maintain quality procedures, work instructions, specifications, and training materials
Review and approve design, product, process, and engineering documentation
Investigate nonconformances, supplier issues, complaints, and CAPAs using root cause analysis techniques
Perform testing, validation activities, data analysis, and reporting to support product quality and compliance
Support design verification and validation activities and product transfers from engineering to manufacturing
Develop inspection plans, test methods, and statistical approaches to ensure product and process conformity
Partner with suppliers and internal teams to improve product quality and manufacturing processes
Assist with complaint investigations, quality event management, change control, and risk assessment activities
Participate in audits, regulatory inspections, and quality system improvement efforts

Requirements

What you’ll need

Bachelor’s degree in Engineering, Physical Science, Business, or a related technical field required
Equivalent combinations of education and experience may be considered
Minimum of 5 years of quality or manufacturing engineering experience in a regulated environment such as medical device, pharmaceutical, biotech, food, aerospace, or automotive industries
Strong problem-solving, troubleshooting, and decision-making abilities
Knowledge of quality engineering principles, statistical methods, and continuous improvement tools
Experience with root cause analysis, FMEA, control charts, DMAIC, PDCA, 5S, and Kaizen methodologies
Understanding of software and electronic design processes and basic electronic test equipment
Strong verbal, written, presentation, and facilitation skills
Ability to work independently and collaboratively in a cross-functional environment
Strong attention to detail with the ability to analyze complex technical information
Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint
Flexible and adaptable in a fast-paced, changing environment

Benefits

Comp & perks

Mission-driven work helping ensure the quality and reliability of technology that positively impacts lives
Meaningful impact on product quality, regulatory compliance, and continuous improvement
Collaborative environment with engineering, manufacturing, procurement, and regulatory teams
Professional growth in medical device quality systems, design controls, and regulatory requirements