Senior Quality Engineer

Maclivaro Limited; Miami (FL); On-site; USD 90,000 - 135,000; Full time

Job summary

Maclivaro Limited, a growing medical device company in Miami, seeks a Principal Quality Engineer to own and strengthen its QMS, lead CAPA and NCR processes, and drive continuous improvement across the business. This hands-on role thrives in a start-up/scale-up setting with evolving processes and limited resources.

You will oversee quality documentation, investigations, supplier quality support, and collaboration with engineering, regulatory, and operations teams to ensure patient safety and

Qualifications

• Experience in ISO 13485 medical device quality environment is highly valuable.
• Background in medical device quality within start-up/scale-up environments.
• Hands-on quality professional comfortable operating with evolving processes and limited resources.

Responsibilities

• Own and manage the Quality Management System (QMS).
• Lead CAPA processes from investigation to effectiveness checks.
• Manage NCRs and drive timely resolution and root-cause analysis.
• Conduct internal and external quality audits and support audit responses.
• Maintain quality procedures, records and controlled documentation.
• Lead quality investigations and problem-solving activities.
• Drive continuous improvement and identify quality risks and opportunities.
• Support supplier quality activities and collaboration with manufacturing teams.

Skills

CAPA management

NCR management

Root cause analysis

Internal audits

QMS maintenance

Documentation control

Corrective and preventive action

Quality investigations

Risk-based thinking

Manufacturing quality

Supplier quality

Regulatory requirements

Job description

Miami, Florida | On-Site | Medical Device

The Opportunity

A growing and entrepreneurial medical device company based in Miami, Florida is looking to appoint a Principal Quality Engineer to play a key role in maintaining, developing and strengthening the company's Quality Management System.

This is a highly hands-on opportunity for an experienced quality professional who enjoys working in a start-up or scale-up environment where processes are still evolving and where there is an opportunity to make a genuine impact.

The successful individual will take ownership of core quality activities including CAPA, NCRs, audits, QMS maintenance, quality documentation, investigations and continuous improvement, while working closely with colleagues across the business.

This is not a role for someone looking to operate within a highly structured corporate environment with narrowly defined responsibilities. The company is looking for someone who is adaptable, practical, curious and willing to get involved across the business.

The Role

As Principal Quality Engineer, you will be responsible for supporting and continuously improving the company's quality systems and processes.

Key responsibilities will include:

• Managing and maintaining the Quality Management System.
• Ownership and management of CAPA processes, including investigation, root-cause analysis, corrective actions, preventive actions and effectiveness checks.
• Managing Non-Conformance Reports (NCRs) and supporting timely investigation and resolution.
• Conducting and supporting internal and external quality audits.
• Supporting audit preparation, responses, corrective actions and follow-up activities.
• Maintaining quality procedures, work instructions, records and controlled documentation.
• Supporting quality investigations and problem-solving activities.
• Performing root-cause analysis and implementing sustainable corrective actions.
• Monitoring quality metrics and identifying trends, risks and opportunities for improvement.
• Supporting supplier quality activities where required.
• Supporting manufacturing and operational teams on quality-related issues.
• Ensuring quality processes are followed and identifying opportunities to strengthen them.
• Supporting continuous improvement initiatives across the organisation.
• Helping develop and implement new quality processes as the business grows.
• Providing practical quality guidance to colleagues across the organisation.
• Supporting regulatory and customer requirements relating to the Quality Management System.
• Taking ownership of quality projects from identification through to completion.

The environment is a key part of this opportunity.

The company is continuing to develop and scale, meaning the successful candidate will need to be comfortable working without all of the processes, resources and infrastructure that would typically exist within a large medical device organisation.

We are therefore specifically looking for someone who has worked within a start-up, early-stage or scale-up medical device business.

You should enjoy:

• Building and improving processes rather than simply following established ones.
• Working across multiple areas of the business.
• Solving problems with limited resources.
• Making decisions and taking ownership.
• Moving quickly when priorities change.
• Getting into the detail when required.
• Finding practical solutions rather than creating unnecessary bureaucracy.
• Working closely with senior leadership and operational teams.
• Having a visible impact on the company's quality culture.

The Ideal Candidate

The ideal candidate will be an experienced Quality Engineer / Senior Quality Engineer / Principal Quality Engineer with a strong background within the medical device sector.

You will ideally have experience with:

• CAPA management.
• NCR / non-conformance management.
• Root-cause analysis.
• Internal and external audits.
• Quality Management Systems.
• Quality documentation and document control.
• Corrective and preventive action.
• Quality investigations.
• Risk-based quality thinking.
• Manufacturing and production quality.
• Supplier quality, where applicable.
• Medical device regulatory and quality requirements.

Experience working within an ISO 13485 medical device quality environment will be highly valuable.

Personality & Mindset

Technical capability is important, but mindset will be equally important.

We are looking for someone who is:

• Adaptable – comfortable with changing priorities and an evolving business.
• Open-minded – willing to consider different approaches and new ideas.
• Creative – able to find practical solutions to difficult problems.
• Hands-on – happy to roll up their sleeves and get into the detail.
• Commercially aware – understands that quality needs to support the business without compromising product or patient safety.
• Curious – naturally interested in understanding why things happen and how they can be improved.
• Proactive – identifies issues before they become larger problems.
• Confident – willing to challenge processes and constructively question the status quo.
• Collaborative – able to work effectively with engineering, operations, manufacturing, regulatory and leadership teams.
• Entrepreneurial – comfortable taking ownership without needing everything to be defined in advance.

The successful candidate will not simply be responsible for maintaining an existing QMS. As the business grows, there will be opportunities to improve processes, introduce better ways of working and help build the quality infrastructure required for the next stage of the company's development.

The Opportunity

This is an opportunity to join a growing medical device company at an exciting stage of its development and have a meaningful influence on its quality systems, processes and culture.

If you are an experienced medical device quality professional who thrives in a start-up environment, enjoys solving problems and wants the opportunity to build, improve and take ownership, this could be an excellent next step.