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Quality Manager Medical Device Jobs in Ohio (NOW HIRING)

Quality Manager

Dayton, OH · On-site

$100K - $130K/yr

... medical device customers and has demonstrated success leading internal and external audits ... Lead and maintain the Quality Management System (QMS) in accordance with ISO 9001 and/or AS9100 ...

Quality Manager

Dayton, OH · On-site

$100K - $130K/yr

... medical device customers and has demonstrated success leading internal and external audits ... Lead and maintain the Quality Management System (QMS) in accordance with ISO 9001 and/or AS9100 ...

Person Responsible for Regulatory Compliance (PRRC) for medical devices, ensuring device conformity to the quality management system and harmonized standards. * Ensures development, communication ...

We are seeking Quality Manager to assist the various department heads in formulating quality ... Experience in Medical Device or other FDA-regulated industry a MUST * Previous experience running ...

Senior Medical Device Engineer

Blue Ash, OH · On-site

$96K - $131K/yr

Senior Medical Device Engineer PLM / Lifecycle Management Location: Blue Ash, OH Duration: 6+ ... Knowledge of Quality Management Systems (QMS), ISO 13485, FDA 21 CFR Part 820/QMSR, and regulatory ...

Quality Manager

Mentor, OH · On-site

$125 - $150/hr

Serve as Management Representative for ISO and certification audits, leading all internal and ... Strong knowledge of ISO 13485, FDA Quality System Regulations (21 CFR §820), and medical device ...

Quality Manager

Mentor, OH · On-site

$100 - $125/hr

Serve as Management Representative for ISO and certification audits, leading all internal and ... Strong knowledge of ISO 13485, FDA Quality System Regulations (21 CFR §820), and medical device ...

Quality Manager PPP NA

Millersburg, OH · On-site

$85K - $90K/yr

Quality Manager PPP NA Main tasks The Quality Manager PPP NA, Gx Berlin, Ohio, is responsible for ... Experience in the plastic injection molding and/or medical device industry preferred. * Excellent ...

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Showing results 1-20

Quality Manager Medical Device information

See Ohio salary details

$22.8K

$81.9K

$150.2K

How much do quality manager medical device jobs pay per year?

As of Sep 7, 2026, the average yearly pay for quality manager medical device in Ohio is $81,911.00, according to ZipRecruiter salary data. Most workers in this role earn between $41,800.00 and $129,300.00 per year, depending on experience, location, and employer.

What does a quality manager do in the medical device industry?

A Quality Manager in the medical device industry is responsible for ensuring that products meet all regulatory requirements and quality standards throughout their lifecycle. They develop, implement, and monitor quality management systems, oversee internal and external audits, and work closely with manufacturing, engineering, and regulatory teams to maintain compliance with standards such as ISO 13485 and FDA regulations. Their role is critical to ensuring patient safety and product efficacy by preventing defects and ensuring consistent quality.

What are the key skills and qualifications needed to thrive as a quality manager in the medical device industry?

To thrive as a Quality Manager in the Medical Device industry, you need a solid background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and process improvement, often supported by a relevant degree in engineering or life sciences. Familiarity with quality management systems (QMS), risk management tools (like FMEA), and certifications such as ASQ Certified Quality Auditor (CQA) or Six Sigma are typically required. Strong leadership, attention to detail, and effective communication are vital soft skills for managing teams and ensuring cross-functional alignment. These skills and qualifications are crucial to ensure product safety, regulatory compliance, and the overall success of medical device manufacturing and delivery.

What are some common challenges quality managers face when ensuring compliance in the medical device industry?

Quality Managers in the medical device industry often encounter challenges such as keeping up with evolving regulatory requirements (like FDA, ISO 13485, and MDR), coordinating cross-functional teams to maintain strict quality standards, and managing documentation for audits. They must also address nonconformities quickly and implement corrective and preventive actions to avoid product recalls. Effective communication and strong attention to detail are essential for navigating these challenges while maintaining product safety and regulatory compliance.

What is the difference between Quality Manager Medical Device vs Quality Engineer Medical Device?

AspectQuality Manager Medical DeviceQuality Engineer Medical Device
Primary FocusOversees quality systems, compliance, and team managementDesigns, develops, and implements quality testing and inspection processes
CertificationsISO 13485, Six Sigma, Lead AuditorISO 13485, Six Sigma, Certified Quality Engineer (CQE)
Work EnvironmentManagement, regulatory compliance, cross-department collaborationProduct testing, process improvement, technical analysis
Industry UsageUsed across organizations to ensure overall quality managementUsed in product development and testing phases

The main difference is that the Quality Manager Medical Device focuses on managing quality systems and compliance at a strategic level, while the Quality Engineer Medical Device concentrates on technical testing and process improvements. Both roles require similar certifications and work within the same industry but serve different functions within quality assurance.

What cities in Ohio are hiring for Quality Manager Medical Device jobs?

Cities in Ohio with the most Quality Manager Medical Device job openings:

Infographic showing various Quality Manager Medical Device job openings in Ohio as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 12% Part Time, and 6% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $81,911 per year, or $39.4 per hour.

Senior Medical Device Quality Engineer

Prophecy Technologies

Blue Ash, OH • On-site

$81K - $110K/yr

Full-time

Re-posted 10 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.