Sr. Quality Engineer - Medical Equipment - Hollywood, FL

About Our Client

This organization develops innovative medical devices focused on improving patient care and clinical outcomes. Operating in a highly regulated environment, the company combines engineering excellence with a commitment to quality, compliance, and operational performance.

• Supporting new product development activities, design controls, supply chain initiatives, and continuous improvement of the Quality Management System.
• Providing quality engineering support for process characterization, process validation, manufacturing transfers, and product or process changes.
• Managing risk management activities, including hazard analyses, FMEAs, risk evaluations, and risk management documentation in accordance with ISO 14971.
• Applying risk-based decision-making to balance regulatory compliance, product quality, patient safety, and business objectives.
• Developing and reviewing validation protocols, validation reports, sampling plans, inspection methods, and supporting objective evidence.
• Leading investigations related to nonconformances, deviations, supplier quality issues, complaints, and CAPA activities, including root cause analysis and effectiveness verification.
• Overseeing supplier quality activities, including supplier qualification, audits, performance monitoring, SCAR management, and Approved Supplier List maintenance.
• Participating in audits, regulatory inspections, training initiatives, quality metric reviews, and continuous improvement programs to enhance quality and operational performance.

MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

• Bachelor's degree in Engineering, Life Sciences, or a related scientific/technical discipline; Master's degree preferred.
• Minimum 7 years of experience within the medical device industry.
• Minimum 5 years of quality engineering or quality assurance experience in a regulated medical device environment.
• Strong knowledge of 21 CFR Part 820/QSR, ISO 13485, ISO 14971, EU MDR, CAPA, complaint handling, supplier controls, and design controls.
• Experience with supplier quality engineering, supplier audits, supplier qualification, SCAR management, and supplier performance improvement.
• Experience with process validation, test method validation, DOE, SPC, GR&R, statistical sampling, process capability studies, and change control.
• Proficiency with Minitab or similar statistical analysis software and strong technical writing and problem-solving skills.
• Experience with Class II medical devices, vascular access products, sterile single-use devices, sterilization validation, or ASQ CQE/CQA certifications preferred.

• Competitive salary and potential for salary growth
• Comprehensive benefits package, including health insurance, retirement plans, and vacation/sick leave
• Opportunities for professional development and career advancement
• A positive work environment that values collaboration and innovation
• Work-life balance and flexible scheduling options
• Access to cutting-edge technologies and resources
• Engaging and challenging projects that foster skill development
• Supportive and inclusive company culture
• Networking opportunities within the industry
• Potential for performance-based bonuses or incentives.

Interested? Apply today.