Senior Quality Engineer

Evergen (Formerly RTI Surgical)

. Act as quality lead for major design and manufacturing projects, ensuring robust risk management and compliance .

Posted 9/24/2026full-timeEden Prairie • Minnesota • United StatesSenior💰 $100,000 - $125,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality management within the medical device industry, focusing on risk management, compliance with global regulatory standards, and leading cross-functional quality initiatives. Proficient in statistical analysis and quality system processes, with a strong ability to mentor and influence teams.

Highest-signal resume keywords

Quality Management System OptimizationRegulatory Standards ComplianceStatistical AnalysisRisk Management (ISO 14971)Six Sigma Black Belt

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality System ProcessesCAPASupplier QualityProcess ValidationReliability EngineeringStatistical TechniquesTechnical WritingProblem Solving MethodologiesInvestigationsAudit Leadership

Soft Skills

Excellent Verbal CommunicationExcellent Written CommunicationMentoringCollaboration

Tools & Technologies

Microsoft Office SuiteQuality Management System Software

Certifications & Qualifications

AATB CertificationCTBS CertificationLead Auditor CertificationASQ – CQEASQ – CBAASQ – CQA

Industry Keywords

Medical Device IndustryFDA QSRISO 13485EU MDRMDSAPCross-Functional ProjectsAuditsRemediation Projects

About the role

Key responsibilities & impact

Act as quality lead for major design and manufacturing projects, ensuring robust risk management and compliance
Own and optimize quality system processes, including CAPA, supplier quality, complaint handling, and statistical techniques
Lead complex investigations and implement systemic corrective/preventive actions
Provide expertise in reliability engineering, process validation, and design for quality
Represent the company as a quality expert during FDA inspections, notified body audits, and supplier audits
Collaborate with executive leadership to align quality strategies with business objectives
Mentor and coach quality engineers across multiple sites or functions

Requirements

What you’ll need

Bachelor’s or Master’s degree in engineering, life sciences, or related discipline
6+ years of progressively responsible quality experience in the medical device industry
Deep knowledge of global regulatory standards (FDA QSR, ISO 13485, EU MDR, MDSAP)
Proven success leading cross-functional projects and influencing at senior levels
Advanced statistical analysis
Risk management (ISO 14971)
Six Sigma Black Belt preferred
Track record of leading successful audits and remediation projects
AATB or CTBS Certification preferred
Lead Auditor Certification preferred
ASQ – CQE, CBA, or CQA preferred
Excellent verbal and written communication
Technical writing
Problem solving methodologies
Microsoft Office Suite
Quality Management System software
Investigations
Statistical techniques
Up to 25% travel, including international
Ability to move or lift objects up to 25 pounds
Frequent (>75%) stationary position while utilizing digital displays
Frequent (>75%) fine manipulation using hands and fingers

Benefits

Comp & perks

Annual CIP bonus opportunity of up to $10,000.00
Paid Time Off (PTO)
401(k) with up to a 6% company match
Holiday pay
Medical, dental, and vision insurance
Short-term and long-term disability coverage
Paid parental leave
Great Place to Work Certified workplace culture