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Manager Fmea Jobs (NOW HIRING)

Weil Group, Inc

Project Manager

Dorado, PR

Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems. * Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply ...

Validation & Engineering Group, Inc

PR · On-site

Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems. * Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply ...

Integrated Resources INC

Quality Manager

Lexington, MA · On-site

Facilitate risk analysis (FMEA, FMECA, PHA, HACCP and other equivalent accepted methods). Analyzes ... Escalate critical risks identified during risk assessments to management. Perform Risk Analysis ...

Validation & Engineering Group, Inc

PR

Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems. * Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply ...

Validation & Engineering Group, Inc

PR · On-site

Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems. * Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply ...

Tjm Industries Inc

Quality Manager

York, PA · On-site

Seeking a Quality Manager in manufacturing company in the York, PA Essential Skills of the Job ... Utilize FMEA's * Conduct quality audits daily throughout the plant * Ensure incoming Quality from ...

Intellectt INC

Senior Manufacturing Engineer

Marlborough, MA · On-site

$94.40K - $129.10K/yr

Experience with risk management (FMEA, PFMEA). * Familiarity with CAD tools and manufacturing systems (ERP/MES). * Strong problem-solving, analytical, and communication skills. Preferred ...

TJM Industries Inc

Quality Manager

York, PA · On-site

Seeking a Quality Manager in manufacturing company in the York, PA Essential Skills of the Job ... Utilize FMEA's * Conduct quality audits daily throughout the plant * Ensure incoming Quality from ...

TJM Industries Inc

Quality Manager

York, PA · On-site

$90K - $110K/yr

Seeking a Quality Manager in manufacturing company in the York, PA Essential Skills of the Job ... Utilize FMEA's * Conduct quality audits daily throughout the plant * Ensure incoming Quality from ...

TJM Industries Inc

Quality Manager

York, PA · On-site

Manage all key quality processes/procedures/policies ... Utilize FMEA's * Conduct quality audits daily throughout the plant * Ensure incoming Quality from ...

Merican

Quality Senior Engineer I

Englewood, CO · On-site

$87.40K - $118.50K/yr

Knowledge of design controls, risk management, FMEA, CAPA, root cause investigation and statistical analysis. * Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry ...

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How much do manager fmea jobs pay per year?

As of May 28, 2026, the average yearly pay for manager fmea in the United States is $61,351.00, according to ZipRecruiter salary data. Most workers in this role earn between $44,000.00 and $69,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Manager FMEA, and why are they important?

To thrive as a Manager FMEA, you need a strong background in engineering or quality management, experience with Failure Mode and Effects Analysis (FMEA), and often a relevant technical degree. Familiarity with FMEA software tools (such as APIS IQ-FMEA or PTC Windchill Quality Solutions), Six Sigma certification, and quality management systems are typically required. Exceptional analytical thinking, leadership, and communication skills help facilitate cross-functional teamwork and problem-solving. These skills ensure accurate risk identification, effective mitigation strategies, and improved product reliability and safety.

What are some common challenges faced by a Manager FMEA and how can they be addressed?

A Manager FMEA (Failure Mode and Effects Analysis) often encounters challenges such as ensuring cross-functional team engagement, maintaining up-to-date documentation, and integrating FMEA findings into overall quality improvement processes. Successfully addressing these challenges requires strong communication skills to foster collaboration among engineering, manufacturing, and quality teams. Additionally, regular training and clear process guidelines help keep documentation current and relevant, while active follow-up ensures that action items identified during FMEA sessions are implemented and tracked effectively.

What are Manager FMEA?

A Manager FMEA (Failure Mode and Effects Analysis Manager) is a professional responsible for overseeing the FMEA process within an organization. Their primary role is to lead teams in identifying potential failure modes in products or processes, assessing the risks associated with them, and implementing corrective actions to improve reliability and safety. They coordinate cross-functional teams, ensure compliance with industry standards, and maintain comprehensive documentation. Strong leadership, analytical, and communication skills are essential for this role. Manager FMEA positions are commonly found in industries such as automotive, manufacturing, and aerospace.

What is the difference between Manager Fmea vs Fmea Engineer?

AspectManager FmeaFmea Engineer
Primary RoleOversees FMEA processes, manages teams, and ensures compliancePerforms detailed FMEA analysis, identifies risks, and recommends improvements
Required CredentialsTypically requires engineering degree, experience in quality or reliability, and leadership skillsEngineering degree, specialized knowledge in FMEA methodologies, and analytical skills
Work EnvironmentManagement setting within manufacturing or engineering firmsTechnical analysis in labs or production environments
Industry UsageCommon in automotive, aerospace, and manufacturing sectorsUsed across similar industries for risk assessment and quality control

The Manager Fmea focuses on leading and coordinating FMEA activities, ensuring team performance and compliance. In contrast, the Fmea Engineer conducts detailed risk analyses and technical assessments. Both roles are essential in quality management, but they differ in scope and responsibilities.

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Manager Fmea jobs near you
Project Manager

Project Manager

Weil Group, Inc

Dorado, PR

Full-time

Posted 14 days ago

Job description

Purpose StatementProvide vision and leadership to strategic projects with significant site impact. Ensure new products are launched from the site in alignment with contract goals. Manage the performance of projects or significant subsystems associated with new products by influencing, coordinating, and driving activities, initiatives, and development deliverables across cross-functional teams. Direct all phases of new product development projects from inception through completion from an Operations perspective. Lead project review sessions focusing on cost, schedule, and technical performance. Establish milestones, monitor adherence to plans and schedules, identify issues, and implement solutions. Demonstrate strong leadership, clear communication, and the ability to build effective cross-functional working relationships. Ensure Value Improvement Projects (VIP) and new product initiatives are completed in alignment with contract expectations.Key Responsibilities
  • Project Planning & Definition: Define project goals, scope, resource and cost estimates, timeline, and risks. Facilitate cross-functional discussions to develop project proposals.
  • People Leadership: Manage large, multi-project, multi-site cross-functional teams; provide performance input; foster strong alignment.
  • Value Improvement (VIP): Oversee VIP initiatives; identify, communicate, and manage risks.
  • Project / Program Management: Lead initiation, planning, execution, control, and close-out activities; ensure team ownership of plans, schedules, and budgets.
  • Process Management: Ensure activities follow established processes; maintain documentation discipline; reinforce VIP and NPE best practices.
  • Communications & Reviews: Drive cross-functional communication; serve as liaison between teams and leadership; lead phase reviews; maintain documentation including minutes, issue logs, and metrics.
  • New Product Excellence (NPE): Implement NPE methods; manage NPE risks and deliverables.
Experience Requirements
  • 5–7+ years of experience in manufacturing engineering or quality engineering within an FDA-regulated industry (medical devices, pharmaceuticals, biotechnology, diagnostics, or similar).
  • Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO 13485.
  • Experience supporting new product introductions (NPI/NPD), including process development, equipment qualification, and process validation.
  • Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems.
  • Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply Chain teams.
  • Familiarity with controlled documentation systems, engineering change processes, and manufacturing readiness requirements.
  • Experience ensuring compliance with quality system procedures and regulatory expectations across the project lifecycle.
Quality System RequirementsDemonstrate a primary commitment to patient safety and product quality by adhering to applicable quality policies, procedures, and requirements.
For roles with direct reports: Ensure adequate resources (personnel, tools, etc.) are in place to support quality compliance and promote a work environment aligned with quality expectations.Job Scope & Leveling Guidelines
  • Functional Knowledge: Applies in-depth conceptual, practical, and technical knowledge; understands related functions.
  • Business Expertise: Applies knowledge of key business drivers and cross-team integration to achieve objectives.
  • Leadership: Provides guidance, coaching, and may lead smaller projects or sub-projects with manageable risk.
  • Problem Solving: Solves problems of varying complexity; adapts or develops solutions using judgment and experience.
  • Impact: Influences project, operational, or service activity effectiveness.
  • Interactions: Communicates complex information clearly; persuades and guides stakeholders in cross-functional settings.
Additional InformationThe above statements describe the general nature and level of work performed and do not represent an exhaustive list of responsibilities. Training requirements are established and tracked through the individual learning plan. For physical requirements, consult the local Environmental Health & Safety (EHS) team. Support a work environment aligned with EHS and Energy Policies.
**Weil Group is proud to be an Equal Employment Opportunity Employer.*