Quality Engineering Manager

Quality Engineering Manager

Miami, Florida, United States | On-Site

Quality Engineering Manager | Medical Devices | Design Controls & Regulatory Compliance

The Opportunity

A growing and entrepreneurial medical device company based in Miami, Florida, is looking to appoint a Quality Engineering Manager to take ownership of quality engineering activities, strengthen design and development controls, and ensure medical products are developed and manufactured in accordance with applicable regulatory and quality requirements.

This is a hands-on leadership opportunity for an experienced medical device quality professional who combines strong technical expertise with a practical, solutions-focused approach. The successful candidate will play a key role in ensuring product quality, regulatory compliance and robust design control throughout the product lifecycle.

Working closely with engineering, R&D, manufacturing, regulatory and senior leadership teams, you will help ensure that quality is embedded into product development and engineering processes from the outset, rather than simply managed through an established Quality Management System.

The company is continuing to grow and evolve, so this role will suit someone comfortable working in a start-up or scale-up medical device environment, where they can take ownership, influence decisions and build effective quality engineering processes as the business develops.

The Role

As Quality Engineering Manager, you will lead and support quality engineering activities across product development, design controls, risk management, regulatory compliance and quality systems.

You will work closely with engineering and product development teams to ensure medical products meet applicable quality, safety and regulatory requirements throughout the design lifecycle. You will also oversee quality investigations, corrective actions and continuous improvement initiatives, helping the business maintain robust processes as it grows.

This is not a purely managerial or administrative position. The successful candidate must be comfortable getting into the technical detail, working directly with engineers and solving complex quality challenges.

Key Responsibilities

Quality Engineering & Design Controls

• Lead quality engineering activities throughout the medical device product development lifecycle, from initial concept and design inputs through verification, validation, design transfer and post-market activities.
• Ensure design control processes are established, implemented and maintained in accordance with applicable medical device regulatory requirements.
• Work closely with R&D, product development and engineering teams to ensure design inputs, outputs, reviews, verification and validation activities are appropriately documented and controlled.
• Review and provide quality input into design and development plans, protocols, reports and technical documentation.
• Ensure Design History Files (DHF) and associated design records are complete, accurate, traceable and compliant.
• Support requirements traceability, design reviews, engineering change control and design transfer activities.
• Provide quality oversight of product development activities, identifying potential compliance gaps and design-related risks early in the process.
• Ensure appropriate application of risk management principles throughout product development, including design FMEAs, hazard analysis and risk mitigation activities.

Regulatory Compliance

• Ensure quality engineering processes align with applicable FDA requirements, including relevant Quality Management System Regulation (QMSR) requirements, and other applicable medical device regulations.
• Support compliance with ISO 13485 and relevant product-specific standards.
• Work alongside Regulatory Affairs to ensure quality and design documentation supports regulatory submissions and product approvals.
• Provide regulatory and quality guidance to engineering and product development teams, helping translate requirements into practical processes.
• Support regulatory inspections, notified body audits and customer audits where applicable.
• Identify regulatory and compliance risks associated with product design, development and manufacturing, and drive appropriate corrective actions.
• Support the development and maintenance of technical documentation and objective evidence required to demonstrate product conformity.

Quality Management & Continuous Improvement

• Maintain and improve the Quality Management System, ensuring it effectively supports product development and the company's regulatory obligations.
• Lead CAPA activities, including root-cause analysis, investigation, corrective and preventive actions, and effectiveness checks.
• Oversee non-conformance management, product investigations and quality issue resolution.
• Lead or support internal and external audits, including audit preparation, responses and follow-up actions.
• Manage engineering change control and ensure changes are assessed for their impact on product quality, risk, validation and regulatory compliance.
• Monitor quality metrics, identify trends and implement improvements to reduce quality risks.
• Support supplier quality and manufacturing quality activities where they affect product conformity or design integrity.
• Develop and improve quality procedures, work instructions and processes as the business scales.

Leadership & Cross-Functional Collaboration

• Provide quality engineering leadership and practical guidance to engineering, R&D, manufacturing and operational teams.
• Build strong working relationships across the business, ensuring quality is considered an integral part of product development and decision-making.
• Challenge design decisions, processes and documentation where necessary to protect product quality, safety and regulatory compliance.
• Take ownership of quality engineering projects and drive them through to completion.
• Help establish a proactive quality culture, encouraging accountability, effective problem-solving and continuous improvement.
• Balance regulatory requirements with commercial priorities, ensuring the business can progress efficiently without compromising product safety or compliance.

The Start-Up Environment

The company is continuing to develop and scale, meaning the successful candidate will need to be comfortable operating in an environment where processes, resources and infrastructure may still be evolving.

This is an opportunity to influence how quality engineering is approached within the business, working directly with technical teams and senior leadership to establish effective, scalable processes.

We are particularly interested in individuals who have worked within a medical device start-up, early-stage business or scale-up environment and understand the challenges of developing products while building the quality and regulatory infrastructure needed to support commercialisation.

You should enjoy:

• Building and improving design control and quality engineering processes.
• Working closely with R&D and engineering teams on technical product-related challenges.
• Supporting product development while maintaining regulatory compliance.
• Taking ownership of quality engineering decisions and projects.
• Working through complex design, risk management and compliance issues.
• Making practical decisions in a resource-conscious environment.
• Moving between strategic oversight and detailed technical work.
• Challenging existing approaches and identifying opportunities to improve.
• Working directly with senior leadership and cross-functional teams.
• Helping a growing medical device business prepare for its next stage of development.

The Ideal Candidate

The ideal candidate will be an experienced medical device quality professional currently working as a Quality Engineering Manager, Design Quality Manager, Senior Quality Engineer, Principal Quality Engineer or in a similar role with significant responsibility for design controls and regulatory compliance.

You will have a strong understanding of medical device product development and be confident working with engineering teams to ensure products are designed, developed and documented in accordance with applicable regulatory requirements.

Essential Experience

• Experience within the medical device industry, ideally in a product development, design engineering or regulated product environment.
• Strong experience with medical device design controls and design and development processes.
• Practical experience with design inputs and outputs, design reviews, verification and validation, design transfer and change control.
• Experience maintaining or reviewing Design History Files (DHF), design documentation and requirements traceability.
• Knowledge of FDA medical device quality requirements, including the QMSR and applicable requirements under 21 CFR Part 820.
• Experience working within an ISO 13485 Quality Management System.
• Strong understanding of risk management, including ISO 14971, risk assessments, FMEAs and risk mitigation.
• Experience supporting product development, engineering or R&D teams on quality and regulatory matters.
• Experience managing CAPA, non-conformances, root-cause analysis and quality investigations.
• Ability to interpret regulatory requirements and translate them into effective, practical quality engineering processes.
• Strong communication skills and the ability to influence technical and non-technical stakeholders.
• Experience working in a medical device start-up or scale-up environment.
• Experience supporting new product development and commercialisation.
• Exposure to FDA submissions, regulatory inspections or notified body audits.
• Experience with engineering change management and design transfer into manufacturing.
• Experience with medical device software, electromechanical products or other technically complex medical products, where relevant.
• Experience establishing or improving design control processes within a growing organisation.
• Previous experience mentoring or leading quality engineers or providing cross-functional quality leadership.

Personality & Mindset

Technical knowledge is essential, but the right mindset will be equally important.

We are looking for someone who is:

• Hands-on: Comfortable reviewing technical documentation, working through design issues and getting into the detail when needed.
• Technically strong: Able to understand product development processes, design controls, risk management and regulatory expectations.
• Adaptable: Comfortable working in an evolving business where priorities can change.
• Proactive: Identifies potential quality and compliance risks before they become larger problems.
• Confident: Willing to challenge engineering decisions and raise concerns constructively.
• Collaborative: Works effectively with R&D, engineering, regulatory, manufacturing and leadership teams.
• Commercially aware: Understands the need to support product development and business growth while protecting product quality and patient safety.
• Solutions-focused: Able to find practical, risk-based solutions rather than creating unnecessary bureaucracy.
• Entrepreneurial: Comfortable taking ownership, making decisions and building processes without needing everything to be defined in advance.
• Quality-driven: Committed to ensuring regulatory compliance and product quality are embedded throughout the product lifecycle.

The Opportunity

This is an opportunity to take a leading role in quality engineering within a growing medical device business, with the scope to influence product development, design controls, regulatory compliance and the wider quality culture.

For an experienced medical device quality professional who enjoys working closely with engineers, strengthening design control processes and helping products progress through development in a compliant and effective way, this offers the chance to make a tangible impact.

If you have strong medical device design control and regulatory experience, enjoy solving technical quality challenges and want to help shape quality engineering within an entrepreneurial business, we would welcome your application.