Medical Device - Senior Quality Engineer - Miami, FL

Job Description

Job Description

Our client is seeking an experienced Senior Quality Engineer to provide hands-on quality engineering support and drive continuous improvement across quality systems, manufacturing processes, supplier quality, and product development activities. This role is critical in maintaining regulatory compliance, supporting operational excellence, and ensuring product quality and patient safety throughout the product lifecycle.

Client Details

Our client is a growing medical device organisation focused on developing innovative products that improve patient outcomes and support healthcare professionals. Operating within a highly regulated environment, the company is expanding its quality and operational capabilities to support ongoing product development and commercial growth.

Description

Responsibilities :

• Support new product development activities, design controls, supplier quality initiatives, and Quality Management System improvements.
• Provide quality engineering support for process characterisation, validation, manufacturing transfer, and change management activities.
• Lead and support risk management activities including hazard analyses, DFMEA, PFMEA, AFMEA, and risk assessments in accordance with applicable standards.
• Review engineering changes and assess quality, validation, and regulatory impacts.
• Develop and review validation protocols, reports, sampling plans, inspection methods, and supporting objective evidence.
• Utilise statistical tools and methodologies including DOE, SPC, process capability studies, GR&R, and trend analysis.
• Investigate nonconformances, deviations, supplier issues, complaints, and CAPAs, including root cause analysis and effectiveness verification.
• Support complaint handling, post-market surveillance, and quality event investigations.
• Lead supplier quality activities including qualification, audits, performance monitoring, SCAR management, and supplier development initiatives.
• Participate in internal audits, supplier audits, and regulatory inspections while supporting audit readiness and response activities.
• Develop, update, and implement quality procedures, work instructions, forms, specifications, and training materials.
• Monitor quality metrics and support management review activities.
• Provide training and guidance on quality systems, regulatory requirements, statistical tools, and good documentation practices.
• Drive continuous improvement initiatives focused on quality, compliance, supplier performance, manufacturing efficiency, and operational excellence.

Profile

Ideal Candidate:

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 7+ years of experience within the medical device industry.
• 5+ years of experience in Quality Engineering or Quality Assurance within a regulated medical device environment.
• Strong knowledge of ISO 13485, ISO 14971, FDA Quality System Regulations, EU MDR, design controls, CAPA, complaint handling, supplier controls, and risk management.
• Hands-on experience with supplier quality engineering, supplier audits, supplier qualification, and supplier performance improvement.
• Experience with process validation, test method validation, change control, statistical sampling, DOE, MSA/GR&R, SPC, and process capability studies.
• Experience supporting regulatory inspections, notified body audits, internal audits, or supplier audits.
• Strong technical writing, communication, organisation, and cross-functional problem-solving abilities.
• Proficiency with Microsoft Office and statistical software such as Minitab.
• Ability to travel domestically and internationally up to approximately 25%.
• Experience with Class II medical devices, sterile single-use devices, outsourced manufacturing, sterilisation validation, or rapidly growing medical device organisations is highly desirable.
• ASQ CQE and/or CQA certifications preferred.

Job Offer

What's To Offer:

• Opportunity to influence quality strategy and systems within a growing medical device organisation.
• Highly visible role partnering with technical, operational, and leadership teams.
• Exposure to new product development, supplier quality, process validation, and regulatory compliance initiatives.
• Collaborative environment focused on innovation, patient safety, and continuous improvement.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.