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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading quality programs within FDA-regulated medical device manufacturing, focusing on compliance, risk management, and operational excellence. Proven ability to mentor teams, manage projects, and implement data-driven quality improvements aligned with regulatory standards.
Highest-signal resume keywords
FDA Regulated Medical Device ManufacturingProgram/Project ManagementQuality Management SystemISO 13485/14971 ComplianceData Analytics and Quality KPIs
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Program DevelopmentRisk ManagementContinuous ImprovementData AnalysisProject PlanningBudgetingPerformance ManagementChange ManagementProcess ImprovementCorrective Actions
Soft Skills
Effective CommunicationInfluencing SkillsTeam LeadershipRelationship BuildingMentoring
Tools & Technologies
Data Analytics ToolsQuality Management SoftwareProject Management Software
Certifications & Qualifications
Six SigmaPMP
Industry Keywords
GMPGDP21 CFRMDD/EU MDRQuality ComplianceOperational Excellence
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Provide strategic leadership for enterprise and site-level quality programs within FDA-regulated medical-device manufacturing environments
- Lead large-scale, global, cross-functional programs that strengthen the quality management system, improve compliance, reduce risk, and advance operational excellence
- Lead, mentor, and manage Program Managers and data analysts
- Develop and implement strategic quality-program plans, including Artificial Intelligence (AI), aligned with organizational goals and regulatory requirements
- Oversee planning, execution, and completion of quality-compliance projects within timelines, budgets, and objectives
- Identify and address risks and issues affecting project success
- Ensure adherence to industry standards, regulatory requirements, and internal quality policies
- Monitor and evaluate quality-program effectiveness and adjust programs to maintain compliance and improve outcomes
- Improve data and analytics tools and practices
- Collaborate with Operations Quality, Operations, Engineering, Business, and Supply Chain
- Serve as primary point of contact for quality-related inquiries and concerns from internal stakeholders
- Prepare and present project-status, performance-metric, and compliance reports to senior management
- Ensure accurate and timely quality-program documentation, including project plans, reports, and compliance records
- Drive continuous improvement through best practices and innovative solutions
- Lead process-improvement initiatives and implement corrective actions
Requirements
What you’ll need- Minimum of 10+ years’ experience in FDA regulated medical device manufacturing/supply chain environments
- Proven track record of successful program/project management, transformation, change management, continuous improvement and team leadership in a matrix environment
- Experience in functional management of PMO/Quality teams, including budgeting, workforce planning, performance management, employee engagement/retention, succession planning, coaching, and training
- Strong understanding of medical device regulations/standards including ISO 13485/14971, 21 CFR (803, 806, 820, etc.), MDD/EU MDR, GMP, and GDP
- Expertise utilizing/improving data analytics, Quality KPIs, and data analysis
- Ability to communicate effectively, influence, and build relationships with cross-functional team members at all levels
- Minimum of a Bachelor's degree in Quality, Engineering, or a related scientific discipline (required)
- Advanced degree or relevant certifications (e.g., Six Sigma, PMP) preferred
- Must successfully perform minimum physical, cognitive, and environmental job requirements with or without accommodation
- US work authorization required; candidates requiring sponsorship now or in the future will not be considered
- Must reside in or within commuting distance to Plymouth, Minnesota or Cambridge, Massachusetts
- Role may require travel up to 25%
Benefits
Comp & perks- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
- Annual incentive bonus may be offered
- Sales commission may be offered
- Long-term incentives may be offered
- Company relocation benefits will not be provided
