Senior Medical Device Quality Engineer - PLM & Risk Lead

VOLTO Consulting; Blue Ash (OH); On-site; USD 95,000 - 140,000; Part time

Job summary

VOLTO Consulting seeks a Medical Device Quality Engineer in Blue Ash, OH for a 6-month engagement. The role requires 7+ years in medical device or regulated industries and experience leading cross-functional technical projects.

You will deepen expertise in design controls, QMS, supplier qualification, and drive risk management, process validation, and design verification activities across engineering, regulatory, and manufacturing teams.

Qualifications

• Must have extensive experience in medical device quality systems and design controls.
• Hands-on knowledge of V&V, tests, protocols, and documentation.
• Strong understanding of risk management methods (ISO 14971, DFMEA, PFMEA).
• Familiarity with QMS requirements (FDA 21 CFR 820) and regulatory compliance.

Responsibilities

• Lead multiple high-priority lifecycle change projects from concept through implementation.
• Drive project plans, timelines, risk mitigation, and readiness.
• Coordinate cross-functional teams across Engineering, Quality, Regulatory, Manufacturing, Supply Chain, and Suppliers.
• Interface with suppliers for component development, DFM reviews, tooling readiness, and qualification.
• Support design verification/validation activities, including test planning and data review.
• Partner with manufacturing on process validation, IQ/OQ/PQ, and production launches.
• Apply design controls, change management, risk management, and regulatory expectations.
• Review engineering drawings, GD&T, tolerances, and acceptance criteria.
• Drive root cause analysis and timely closure of project issues.
• Communicate status, risks, decisions and recommendations to stakeholders and leadership.
• Demonstrate ownership, urgency, accountability, and influence without authority.

Skills

Medical device quality

Design controls

QMS (ISO 13485)

Regulatory familiarity

Risk management

DFMEA/PFMEA

CAPA

DFM

Project leadership

Supplier quality

Job description

ocation: Blue Ash, OH

Duration: 6 months

Role Descriptions: 7+ years of engineering experience in medical device or other regulated industries. Experience leading cross-functional technical projects.

Role: Medical Device Quality Engineer

Location: Blue Ash, OH

Duration: 6 months

Role Descriptions: 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.

Must Have Technical/Functional 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, with the ability to drive decisions and deliver results without direct authority.

Roles & 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.

Generic Managerial Skills, If Any

Strong communication skills, with proficiency in reading, writing, and speaking English.

Ability to multitask, understand customer requirements, and respond promptly and accurately.

Capability to prioritize and manage multiple tasks in a fast paced environment.

Ability to understand and follow complex written procedures.

Ability to work effectively in a team environment and contribute to team goals.

Strong decision making and problem solving abilities with sound situational judgment.

Essential Skills: EIS : MDD Risk Management