Quality Engineer Jobs

At IntuiTap Medical, we are eliminating guesswork, frustration, and pain from spinal needle placements. VerTouch, our handheld, easy-to-use device, combines tactile imaging and needle localization to enable accurate placement of needles for lumbar punctures, epidurals, and spinal anesthesia. The company is preparing for its market approval and growth through the commercialization phase. This is an opportunity to join a dynamic growing company with a exciting and flexible work environment.

Summary

The purpose of this position is to maintain medical device quality assurance activities for IntuiTap Medical. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will support all aspects of the quality system including, non-conforming product and device complaint investigation, review, and processing of changes within the quality system, supplier review and approval and general quality process improvements.

This is a technical role requiring problem identification, solution development and implementation capabilities. The position will report to the head of operations and engineering and work collaboratively with the product development engineering team.

IntuiTap operates a hybrid work model blending in-office and remote work as activities or projects require. Candidates will need to be located within the Chicago metropolitan area and able to attend IntuiTap’s Chicago office located at mHub on Chicago Avenue up to 1-2 times per week.

Principal Responsibilities

·Ensure product development, manufacturing post market support activities are conducted compliant with the company’s quality system, applicable standards, and guidances.

·Ensure engineering activities, product and regulatory changes and enhancement are completed consistent with the company quality system.

·Develop and implement quality control methodologies and testing plans for all company activities.

·Enhance and maintain the quality management system.

·Evaluate the effectiveness of quality control procedures, propose, and implement improvements.

·Evaluate and analyze product and quality system feedback, identify areas of improvement, develop and implement solutions.

·Complete non-conforming product and system investigations. Conduct any required analysis and testing to clearly identify solutions.Coordinate corrective action and their implementation in conjunction with product development team. Follow up and ensure corrective and preventive action are effective.

·Complete CAPA investigation and coordinate the implementation of corrective and prevention activities.

·Collaborate with cross-functional teams to ensure that quality standards are met throughout the product development, manufacturing and on market lifecycle stages.

·Ensure compliance with regulatory requirements, international standards, and company policies.

Qualifications:

Required

·Bachelor's degree in a relevant engineering discipline such as biomedical, mechanical or similar

·Minimum of 4-6 years of engineering experience with the MedTech industry in a quality engineering or similar role.

·Knowledge of regulatory requirements and quality management systems

·Experience working with product management and quality systems software systems.

·Prior experience working with a contract manufacturer within the medical device industry.

·Experience working in medical device quality system and regulatory environments.

·Exceptional written and oral communication skills targeting technical and non-technical audiences.

·High level of competence with MS office tools and specifically Word and Excel.

·Team player that enjoys working in a collaborative team culture.

·Familiarity with start-up environments and able to successfully balance business and quality system needs to achieve company objectives.

·Strong analytical and problem-solving skills, with experience in data analysis and interpretation

·Excellent communication, interpersonal, and leadership skills

·Ability to work effectively in a team environment.

·Good project management skills with the ability to manage multiple projects simultaneously.

Preferred

·Experience with the Arena product lifecycle management system

• Basic programing skills for the automation of quality system activities