Quality Engineering Senior

Principal Quality Engineer Miami, Florida | On-Site | Medical Device

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. 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.
Conducting and supporting internal and external quality audits.
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.
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 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.
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.

Root-cause analysis.
Quality Management Systems.
Quality documentation and document control.
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.

Creative – able to find practical solutions to difficult problems.
Commercially aware – understands that quality needs to support the business without compromising product or patient safety.
Collaborative – able to work effectively with engineering, operations, manufacturing, regulatory and leadership teams.
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.

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.