Description

　　The Quality Engineer I (QE1) plays a critical role in ensuring the quality, safety, and regulatory compliance of medical devices throughout the new product development lifecycle. The QE1 works closely with cross-functional teams to conduct risk assessments, generate verification plans/reports, and maintain quality management system requirements. This role requires a commitment to maintaining the highest standards of quality in the medical device industry. This position reports to the ICG Engineering Manager.

　　Essential Duties, Responsibilities and Qualifications may include the following. (Other duties may be assigned.)

　　New Product Development:

　　Collaborate with cross-functional teams to integrate quality requirements into the design, development, and manufacturing processes of medical devices.

　　Develop and implement quality plans, protocols, and procedures in accordance with regulatory requirements (e.g., ISO 13485, FDA QSR).

　　Conduct risk assessments and contribute to the design and development of risk mitigation strategies for medical devices.

　　Lead and participate in design control activities, ensuring compliance with applicable standards and regulations.

　　Design and execute product testing protocols, including verification and validation testing.

　　Investigate and analyze product defects or failures during the new product development process.

　　Support regulatory submissions and communicate with regulatory agencies as needed.

　　Quality Assurance:

　　Review and audit new product development documentation to meet quality system requirements.

　　Utilizes statistical techniques and programs to make quality decisions.

　　Drive continuous improvement initiatives to enhance product quality and reliability within the infection control and guidance product families.

　　Provide training and support to team members on quality processes and best practices.

　　Stay abreast of industry trends, standards, and regulations related to product quality.

　　Personal Development:

　　Attends all relevant training.

　　Commitment to growing professionally by utilizing a career development plan

　　Qualifications

　　To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

　　Education and/or Experience

　　Minimum of a bachelor’s degree (BS) in engineering from a four-year college or university; one to two years related experience and/or training; or equivalent combination of education and experience.

　　Other Skills and Abilities

　　Demonstrates documentation, process management, root cause investigation, quality analysis tool, and troubleshooting/problem solving skills.

　　Demonstrates interpersonal and self-management skills.

　　Experience with Microsoft Office (Excel, Word, PowerPoint, Outlook, Teams).

　　Prefer experience with manufacturing processes such as heat sealing, injection molding, machining and assembly.

　　Must possess strong organizational skills and attention to detail.

　　Regular attendance is required for the ability to complete work.

　　Requires face-to-face interaction with team members, peers and management to complete work and provide support.

　　Physical Demands

　　The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

　　While performing the duties of this job, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; climb or balance and stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.

　　Work Environment

　　The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

　　While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to toxic or caustic chemicals and the risk of electrical shock. The noise level in the work environment is usually moderate.

　　Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

　　The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)