Quality Engineer

Quality Engineer (Sterilization)The Quality Engineer plays a key role in ensuring that innovative medical devices meet rigorous internal and external quality standards. In this position, you collaborate closely with doctors and engineers to develop creative, high-quality products, define methods and equipment for measuring quality, and support regulatory and quality assurance activities. You also partner with and train quality inspectors and technicians, help lead a junior Quality Engineer, and drive continuous improvement by identifying defects, uncovering their root causes, and implementing effective solutions.ResponsibilitiesCollaborate with doctors and engineers to develop creative, high-quality medical devices that meet regulatory and customer expectations.Define and implement appropriate methods, measurement techniques, and equipment to assess and control product quality.Participate in and support internal and external quality audits, ensuring compliance with applicable standards and regulations.Maintain and oversee document control processes to ensure accurate, current, and compliant quality documentation.Support sterilization processes and verification activities to ensure medical devices meet required sterilization standards.Contribute to the development, maintenance, and improvement of the Quality Management System (QMS) in alignment with ISO and GMP requirements.Identify defects and nonconformities in products and processes, investigate their origin, and implement effective corrective and preventive actions using root cause analysis.Assist in regulatory and quality assurance efforts to ensure products conform to US FDA and international regulatory requirements.Partner with and train quality inspectors and technicians on quality standards, procedures, and inspection techniques.Support supplier quality management activities, including supplier approval, auditing, and oversight of incoming inspection processes.Participate in new product development activities for medical devices, ensuring quality requirements are integrated into design and manufacturing.Use statistical analysis tools, including Minitab, to analyze data, monitor process performance, and support data-driven decision making.Prepare clear, concise technical and quality documentation, including reports, procedures, and work instructions.Collaborate with leadership, including the VP of Quality, and help guide and support a junior Quality Engineer.Contribute to continuous improvement initiatives to enhance product quality, process robustness, and overall quality system effectiveness.Essential Skills & QualificationsBachelor's degree in Engineering or a related scientific discipline.At least 1 year of experience as a Quality Engineer, Quality Technician, or Microbiologist in the medical device industry.Experience with sterilization processes and related quality controls in a medical device context.Strong communication skills, with the ability to collaborate effectively with cross-functional teams including doctors, engineers, and quality staff.Strong analytical and technical writing skills for preparing reports, procedures, and quality documentation.Hands-on experience with Quality Management Systems (QMS).Experience performing internal and external quality audits.Experience with document control processes within a regulated environment.Experience supporting new product development of medical devices.Working knowledge of US FDA and international regulatory requirements for medical devices.Experience with supplier quality management, including supplier approval, auditing, and incoming inspection.Familiarity with ISO and Good Manufacturing Practice (GMP) requirements.Proficiency in root cause analysis methodologies to investigate and resolve quality issues.Experience using statistical analysis software, including Minitab.ASQ certification is preferred.Experience with PPAP (Production Part Approval Process) or similar qualification processes.Experience working within a formal quality management system for medical devices.Ability to work independently while also contributing effectively to a small, growing team.Demonstrated ability to train and mentor quality inspectors, technicians, or junior engineers.Strong attention to detail and a continuous improvement mindset.Work EnvironmentThis role is based in an office setting within a brand-new, modern building in the Kendall area. The quality team operates from a high-rise office, while a separate two-story facility houses a surgery center on the first floor and the design team on the second floor, fostering close collaboration between clinical and engineering functions. The company is a growing medical device organization of approximately 40 individuals that has expanded every year, offering a dynamic environment where your work directly supports individuals who are severely injured. The workplace culture emphasizes flexibility, collaboration, and innovation, with a professional yet supportive atmosphere and opportunities to work closely with both technical and clinical professionals.Job Type & LocationThis is a Contract to Hire position based out of MIAMI, FL.Pay and BenefitsThe pay range for this position is $35.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a fully onsite position in MIAMI,FL.Application DeadlineThis position is anticipated to close on Aug 14, 2026.