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Director, Quality Engineering
Owens & Minor. Develop and execute the global Quality Engineering strategy aligned with Quality Assurance, product-development, manufacturing, and business priorities .
Posted 10/2/2026full-timeRichmond • Virginia • United StatesLead💰 $170,000 - $190,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Quality Engineering, including leadership in design controls, risk management, process validation, and statistical methods within regulated medical device environments. Proven ability to develop and implement Quality Engineering strategies and standards while leading high-performing teams across multiple locations.
Highest-signal resume keywords
Quality Engineering LeadershipDesign ControlsProcess ValidationStatistical MethodsSupplier Quality Management
ATS Keywords
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Hard Skills
Quality EngineeringRisk ManagementProcess ValidationStatistical AnalysisDesign TransferInspection PlanningProcess CapabilityFailure InvestigationRoot-Cause AnalysisCost-of-Quality Improvement
Soft Skills
People LeadershipCoachingTalent DevelopmentCommunicationProblem Resolution
Certifications & Qualifications
Certified Quality EngineerCertified Manager of Quality/Organizational ExcellenceLean Six Sigma
Industry Keywords
Regulated Medical DeviceISO 13485ISO 14971Quality AssuranceProduct LifecycleManufacturing Quality SystemsCross-Functional CollaborationPerformance IndicatorsContinuous ImprovementGovernance
About the role
Key responsibilities & impact- Develop and execute the global Quality Engineering strategy aligned with Quality Assurance, product-development, manufacturing, and business priorities
- Lead the global Quality Engineering function and direct Quality Engineering professionals, managers, and technical teams supporting manufacturing and distribution operations
- Establish Quality Engineering standards, governance, processes, tools, and performance expectations across the product lifecycle
- Provide technical Quality leadership for product development, manufacturing, distribution, and post-market management
- Embed prevention-based Quality Engineering practices from early product development and new-product introduction through commercial manufacturing, distribution, and post-market activities
- Partner with Research and Development, Operations, Engineering, Product Supply, Supplier Quality, Regulatory Affairs, and other functions
- Lead design controls, risk management, product and process development, process validation, inspection planning, statistical methods, and process capability activities
- Direct Quality Engineering support for new-product introductions, design transfers, manufacturing transfers, process changes, product changes, and other technical initiatives
- Analyze Quality and operational data and establish programs to improve product quality, process robustness, manufacturing capability, and operational efficiency
- Establish data-driven monitoring systems and performance indicators to identify risks, predict outcomes, and support corrective action
- Standardize, integrate, and continuously improve Quality Engineering practices across manufacturing and distribution locations
- Lead failure investigations, root-cause investigations, corrective and preventive actions, nonconformances, complaints, and product-quality concerns
- Provide plant-based and distribution Quality support, including process reliability, problem resolution, complaint investigations, document control, cost-of-quality improvement, and corrective and preventive actions
- Drive continuous improvement using Quality data, cost-of-quality information, statistical methods, and engineering controls
- Provide functional direction for Supplier Quality activities and strengthen supplier selection, qualification, monitoring, development, and performance management
- Review Quality Engineering performance, identify systemic risks and trends, and recommend improvement, remediation, or investment priorities
- Update senior leadership on significant technical Quality risks, product and process performance, and recommended actions
- Escalate significant product-quality, process, supplier, customer, and regulatory risks through leadership and governance channels
- Establish priorities, allocate resources, and ensure Quality Engineering capabilities meet business needs
- Build, lead, coach, and develop a high-performing Quality Engineering organization with clear expectations and accountability
- Develop talent and succession plans to strengthen technical expertise, leadership capability, continuity, and retention
- Demonstrate excellent guest service to internal team members
- Perform other related duties as assigned
Requirements
What you’ll need- Bachelor’s degree in engineering, science, statistics, quality, or a related technical discipline required; master’s degree preferred
- 12+ years of progressive Quality Engineering, product-development Quality, or manufacturing Quality experience within a regulated medical device or similarly regulated environment
- 5+ years of progressive people-leadership experience, including responsibility for leading Quality Engineering professionals, managers, or highly specialized technical teams
- Experience providing Quality Engineering leadership across multiple manufacturing facilities, distribution operations, business units, or geographic locations
- Demonstrated experience developing and implementing Quality Engineering strategies, standards, processes, and technical capabilities
- Extensive experience with design controls, product and process risk management, process validation, inspection planning, statistical methods, and process capability
- Demonstrated experience supporting product development, new-product introduction, design transfer, manufacturing transfer, process changes, and commercial manufacturing
- Strong knowledge of applicable FDA and international medical device Quality requirements, including ISO 13485, ISO 14971, and other relevant standards
- Demonstrated experience leading complex failure investigations, root-cause analysis, corrective and preventive actions, nonconformance management, and effectiveness verification
- Experience using Quality data, statistical analysis, cost-of-quality information, and performance indicators to identify risks and improve product and process outcomes
- Experience supporting Supplier Quality activities, including supplier selection, qualification, monitoring, development, and performance management
- Demonstrated experience leading the standardization, integration, or transformation of Quality Engineering practices across multiple locations
- Experience partnering with Research and Development, Operations, Engineering, Product Supply, Supplier Quality, Regulatory Affairs, and other cross-functional leaders
- Demonstrated experience communicating significant technical Quality risks, performance trends, and recommendations to senior leadership
- Certified Quality Engineer, Certified Manager of Quality/Organizational Excellence, Lean Six Sigma, or equivalent certification preferred
- Strong leadership and technical expertise in Quality Engineering within a regulated medical device or manufacturing environment
- Advanced knowledge of design controls, risk management, process validation, statistical methods, inspection planning, process capability, and manufacturing Quality systems
- Strong understanding of the product lifecycle, including product development, new-product introduction, design transfer, commercial manufacturing, distribution, and post-market activities
- Strong people-leadership, coaching, talent-development, and succession-planning capabilities
- Demonstrated ability to lead managers, technical professionals, and geographically dispersed teams
- Ability to work independently in a fast-paced, cross-functional environment
- Ability to lift to 15 lbs. independently and not exceed 50 lbs. without help
Benefits
Comp & perks- Comprehensive healthcare plan including medical, dental, and vision plans starting on day one for full-time teammates
- Educational assistance for eligible teammates enrolled in an approved, accredited collegiate program
- Employer-paid life insurance and disability coverage
- Voluntary supplemental life, hospitalization, critical illness, and other insurance programs
- Adoption assistance
- Fertility benefits through the medical plan
- Parental leave
- Health Savings Account (HSA)
- 401(k)
- Paid sick days, short-term leave, holidays, vacation days, personal days, and additional leave
- Teammate Assistance Program (TAP)
- Calm Health
- Cancer Resources Services
- Discount programs
- Potential for 20% annual bonus