Quality Engineer I

Coordinates and executes projects to improve quality, engineering, and production systems. This position will support new product development (NPD), continuous improvement initiatives, Quality Management System (QMS) compliance, production operations, and post-market activities including complaint handling, nonconformances, and CAPA.

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

1. Quality Assurance:

• Ensure compliance with 21 CFR Part 820, ISO 13485, MDSAP, and other relevant standards.
• Lead and document investigation, root cause analysis, and corrective action plans for quality related issues such as corrective actions, complaints and non-conforming products.
• Responsible for project management and tracking of corrective action plan implementation.
• Support internal and external audits of CIVCO quality system.
• Support establishment and maintenance of quality inspection plans/methods to ensure incoming product meets quality standards per specification documentation.
• Support data collection and reporting on established quality metrics.

2. Product Development and Design Changes:

• Develop, document, and execute new product verification testing primarily on product line extensions.
• Review and audit product structures, drawings, specifications, and design control documentation for completeness and application to CIVCO ISO 13485 quality system.
• Able to make decisions on simple technical matters related to verification, inspection and testing.
• Supports initiatives to improve product quality metrics.
• Provide quality support for product lifecycle management and product end-of-life activities.

3. Process Improvement and Manufacturing Support:

• Able to identify and support operations and quality process improvement projects primarily for small, department level projects
• Review and support manufacturing equipment and process qualifications including IQ/OQ/PQ
• Evaluate and determine product disposition for non-conforming product

4. Personal Development:

• Attends all relevant training.
• Keeps up to date of relevant developments in technology.
• Utilizes statistical techniques and programs to make quality decisions.

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 accommodation 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 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 risk of electrical shock. The noise level in the work environment is usually moderate.