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Risk Management Quality Engineer Jobs in Ohio (NOW HIRING)

Battelle

Quality Engineer

Columbus, OH · On-site

$75K - $95K/yr

The Quality Engineer contributes to risk management, design controls, manufacturing and supplier quality, data-driven problem solving, and continuous improvement initiatives in support of high ...

Battelle Memorial Institute

Quality Engineer

Columbus, OH · On-site

$75K - $95K/yr

The Quality Engineer contributes to risk management, design controls, manufacturing and supplier quality, data-driven problem solving, and continuous improvement initiatives in support of high ...

Midmark

R+D Quality Engineer III

Versailles, OH

$66K - $86K/yr

Leads all risk management processes and creates risk management documentation for (NPD) projects ... Certified Quality Engineer (CQE), Six Sigma Blackbelt (DMAIC, DMADV), and Certified Reliability ...

Midmark Corporation

R+D Quality Engineer III

Versailles, OH · On-site

$66K - $86K/yr

Leads all risk management processes and creates risk management documentation for (NPD) projects ... Certified Quality Engineer (CQE), Six Sigma Blackbelt (DMAIC, DMADV), and Certified Reliability ...

Actalent

Quality Engineer

Vandalia, OH

$67K - $87K/yr

Quality Engineer The Quality Engineer supports quality and compliance activities for new labeling ... Experience with risk management tools such as FMEA and hazard analysis, ideally aligned with ISO ...

New

Cleveland Gear Co

Be Seen First

Supplier Quality Engineer II

Cleveland, OH · On-site

$90K - $110K/yr

CLEVELAND GEAR Supplier Quality Engineer II Join a well-established manufacturing team focused on ... The role emphasizes ISO 9001:2015 compliance, supplier risk management, and the development and ...

Dtna

Quality Assurance Engineering

Byesville, OH

$78K - $100K/yr

Inside the Role The Quality Engineer supports quality assurance initiatives, manufacturing ... Risk Management & Quality Planning * Lead or facilitate Process Failure Mode and Effects Analysis ...

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Risk Management Quality Engineer information

What is the difference between Risk Management Quality Engineer vs Quality Engineer?

AspectRisk Management Quality EngineerQuality Engineer
CertificationsISO 9001, Six Sigma, Risk Management certificationsISO 9001, Six Sigma, Quality Management certifications
Work EnvironmentManufacturing, aerospace, automotive, industries with risk assessment focusManufacturing, software, healthcare, quality assurance roles
Primary FocusIdentifying and mitigating risks to ensure product safety and complianceEnsuring product quality, process improvements, defect reduction

The Risk Management Quality Engineer focuses on identifying and mitigating risks to ensure safety and compliance, often working in industries like aerospace and automotive. In contrast, a Quality Engineer concentrates on improving product quality and reducing defects across various sectors. While both roles require similar certifications and work environments, their core responsibilities differ in scope and focus.

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Risk Management Quality Engineer jobs near you

Senior Medical Device Quality Engineer

Prophecy Technologies

Blue Ash, OH • On-site

$81K - $110K/yr

Full-time

Posted 24 days ago

Job description

Role Overview:
This Senior Medical Device Quality Engineer role involves leading multiple high-priority lifecycle change projects from concept through implementation within the medical device or other regulated industries. The position requires strong expertise in design controls, risk management, quality management systems, and process validation to ensure regulatory compliance and product quality.
Key Responsibilities:
  • Lead multiple high-priority lifecycle change projects from concept through implementation.
  • Drive project plans, timelines, risk mitigation strategies, and implementation readiness.
  • Coordinate cross-functional teams across Engineering, Quality, Regulatory, Manufacturing, Supply Chain, Procurement, Operations, and external suppliers.
  • Serve as the technical interface with suppliers for component development, DFM reviews, tooling readiness, process capability, and component qualification.
  • Support design verification and validation activities, including test planning, execution, data review, and technical documentation.
  • Partner with manufacturing sites on process validation activities, including IQ/OQ/PQ, pilot builds, validation builds, and production launch readiness.
  • Apply strong knowledge of design controls, engineering change management, risk management, quality system requirements, and regulatory expectations.
  • Review engineering drawings, specifications, GD&T requirements, tolerance analyses, and component acceptance criteria.
  • Drive root cause analysis, technical problem solving, and timely closure of project issues.
  • Communicate project status, risks, decisions, and recommendations clearly to stakeholders and senior leadership.
  • Demonstrate strong ownership, urgency, accountability, and ability to influence without direct authority.

Required Skills:
  • Strong expertise in Medical Device Product Lifecycle Management (PLM), Design Controls, and Engineering Change Management (ECO/ECN/ECR).
  • Hands-on experience with Design Verification & Validation (V&V), test methods, protocol development, and technical documentation.
  • Deep understanding of Risk Management methodologies, including ISO 14971, DFMEA, PFMEA, and hazard analysis.
  • Knowledge of Quality Management Systems (QMS), ISO 13485, FDA 21 CFR Part 820/QMSR, and regulatory compliance requirements.
  • Experience in Supplier Quality Engineering, component qualification, supplier development, and Design for Manufacturability (DFM).
  • Proficiency in Process Validation activities including IQ/OQ/PQ, pilot builds, validation builds, and manufacturing transfer.
  • Ability to interpret engineering drawings, GD&T, tolerance stack-ups, specifications, and acceptance criteria.
  • Strong root cause analysis and problem-solving skills utilizing 8D, CAPA, 5 Why, Fishbone, and corrective action processes.
  • Excellent project management skills, including planning, scheduling, risk management, stakeholder management, and cross-functional coordination.
  • Effective leadership, communication, and influencing skills.
  • EIS : MDD Risk Management.

Qualifications:
  • 6-8 years of experience required.
  • 7+ years of engineering experience in medical device or other regulated industries.
  • Experience leading cross-functional technical projects.
  • Experience with component development, supplier qualification, design verification, and manufacturing validation.
  • Strong understanding of design controls, change management, risk management, process validation, and quality system compliance.

Preferred Skills:
  • EIS : New Product Development (NPD) Methodology and Management.

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