Senior Quality Engineer

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.

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

• 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.

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

• CAPA management.
• NCR /…