Quality Assurance Engineer

Solventum

. Serve as Quality/Design Assurance lead and subject matter expert for product Lifecycle Management and Quality Systems for newly acquired Solventum Restorative Healing Technologies products and systems .

Posted 9/17/2026full-timeSan Antonio • Minnesota • United StatesSeniorLead💰 $124,000 - $170,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality and Design Assurance for medical devices, focusing on risk management, design verification, and compliance with industry standards. Proven ability to lead cross-functional teams and mentor engineers while ensuring adherence to quality systems and regulatory requirements.

Highest-signal resume keywords

Quality Engineering ExpertiseISO 13485 KnowledgeRisk Management ActivitiesDesign Verification and ValidationCAPA Problem-Solving

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Test Method ValidationDesign TransferProcess VerificationRoot Cause InvestigationQuality Plans DevelopmentPost-Market SurveillanceStatistical AnalysisRisk AnalysisRegulatory ComplianceManufacturing Quality Assurance

Soft Skills

MentoringCross-Functional CollaborationProblem-SolvingCommunication

Tools & Technologies

Quality Management Systems (QMS)CAPA SystemsDesign Control ToolsStatistical Process Control (SPC)

Certifications & Qualifications

Certified Quality Engineer (CQE)Six Sigma Certification

Industry Keywords

Medical Device ComplianceFDA CFR 820ISO 14971EU Medical Device Directive Regulation 2020IEC 62366Quality SystemsLifecycle ManagementRegulated Industry Experience

About the role

Key responsibilities & impact

Serve as Quality/Design Assurance lead and subject matter expert for product Lifecycle Management and Quality Systems for newly acquired Solventum Restorative Healing Technologies products and systems
Provide medical device quality engineering expertise for test method validation, requirements and risk management, design verification and validation, design transfer, and process verification and validation
Lead cross-functional quality activities involving Design Verification, Stability, Post-Market Surveillance, Complaint Handling, Usability/Human Factors, Software Quality, Manufacturing Quality, and Supplier Quality
Lead risk management activities in accordance with ISO 14971, including risk management plans, risk analyses, and final risk management reports
Develop quality plans for new products using historical quality data and ensure measurable quality objectives
Review and approve production release documentation, including specifications, drawings, labeling, process validations, and change management records
Partner with Quality Assurance, Manufacturing Engineering, and Supplier Quality to ensure readiness for new components and assemblies
Lead post-market surveillance and lifecycle quality activities by evaluating complaints, CAPAs, field performance data, and service records
Incorporate post-market surveillance findings into risk files, design changes, quality plans, and product lifecycle decisions
Lead root cause investigations and CAPA problem-solving activities
Provide QMS process integration support for design and risk files
Support integration of acquired Restorative Healing Technologies quality systems into Solventum processes and procedures
Mentor lower-level engineers and support audit readiness for internal, corporate, notified body, and regulatory inspections
Comply with corporate policies, procedures, and security standards

Requirements

What you’ll need

Bachelor’s degree or higher in an engineering or science discipline, completed and verified prior to start
Seven (7) years of design or quality engineering experience in a regulated industry
Scientific knowledge and experience in product development of medical devices
Knowledge of country-related regulations and standards applicable to medical device compliance
Knowledge of ISO 13485, FDA CFR 820/820.30/812, ISO 14971, EU Medical Device Directive Regulation 2020, IEC 62366, or ISO 10993
ASQ certification such as Certified Quality Engineer (CQE), or willingness to obtain
Six Sigma experience and/or certification related to the design and manufacture of new products
Must be legally authorized to work in country of employment without employment visa sponsorship

Benefits

Comp & perks

Medical, Dental & Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Voluntary Benefits
Paid Absences
Retirement Benefits
Relocation assistance may be authorized
Hybrid work arrangement