Quality Engineer II

Description

Coordinates and executes projects to improve quality, engineering, and production systems. This position will support new product development (NPD), on-market products, continuous improvement initiatives, Quality Management System (QMS) compliance, production operations, and post-market activities. The role requires strong knowledge of FDA, ISO 13485, EU MDR, and other applicable regulatory requirements, as well as hands-on experience with risk management, product validation, and cross-functional collaboration.

Essential Duties and Responsibilities include the following (Other duties may be assigned):

1. New Product Development and Changes to On-Market Products:

• Partner with project team to ensure design controls are implemented effectively and meet regulatory requirements.

• Develop, document, and execute product verification testing for products within and outside of existing product lines and changes to on-market products.

• Define and execute verification and validation (V&V) plans, including test method development, equipment validation, and statistical analysis.

• Support Failure Mode and Effects Analysis (FMEA) and ensure risk management files are comprehensive and compliant with ISO 14971.

• Provide quality input to design reviews and ensure appropriate documentation for design history files (DHFs).

• Able to make decisions on technical matters related to areas such as inspection and testing.

1. Process Improvement and Manufacturing Support:

• Able to identify, coordinate, and execute manufacturing and business process improvement projects.

• Review new technology equipment and process qualifications including IQ/OQ/PQ.

• Evaluate and determine product disposition for non-conforming product.

• Implement and monitor quality metrics (KPIs) to drive continuous improvement initiatives.

1. Quality Assurance:

• Ensure compliance with 21 CFR Part 820, ISO 13485, MDSAP, EU MDR, UK MDR, and other relevant standards.

• Investigate, determine, and document root cause and corrective action for quality related issues such as corrective actions and non-conforming product.

• Review and audit product structures, drawings, specifications and procedures for completeness and application to CIVCO ISO 13485 quality system.

• Investigate, determine, and respond to customer complaints including OEM complaints.

• Support internal audits of CIVCO and external supplier audits as necessary.

• Drive improvements to QMS processes to enhance efficiency and compliance.

• Monitor and analyze product performance and customer feedback to identify trends.

• Provide quality support for product lifecycle management and end-of-life activities.

1. Personal Development:

• Attends all relevant training and actively pursues further training/education.

• Keeps abreast of relevant developments in technology.

• Utilize statistical techniques and programs to make quality decisions.

1. Leadership and Supervision

• Able to provide mentoring and coaching within Quality department and broader organization.

• Able to supervise and manage quality engineering internship program (as applicable).

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

Education and/or Experience:

Minimum of a Bachelor's degree (BS) in engineering from a four year college or university; and three to five 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 and statistical analysis programs such as Minitab.

• Experience with manufacturing processes such as heat sealing, injection molding, machining, and assembly.

• Prefer experience in a regulated environment such as ISO 13485.

• Prefer experience with Six Sigma and Lean principles.

• 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 individual is located in a permanent or temporary laboratory location or production environment. Work may involve occasional exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, smoke, unpleasant odors, and/or loud noises. 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)

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.