Quality Engineer

Job Title:

Quality Engineer (Sterilization)

Job Description

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.

Responsibilities

* Collaborate 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 & Qualifications

* Bachelor'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 Environment

This 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…