Quality Engineer II

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. The role requires strong knowledge of FDA, ISO 13485, and other applicable regulatory requirements, as well as hands‑on experience with risk management, product validation, and cross‑functional collaboration.

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

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

• 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.

• Ensure compliance with 21 CFR Part 820, ISO 13485, MDSAP, 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.
• Execute internal audits of CIVCO business unit quality system.
• Plan, execute and report on external supplier audits.
• 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.

• 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.

• Able to provide mentoring and coaching within Quality department and broader organization.
• Able to supervise and manage quality engineering internship program (as applicable).

• 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 with electrical devices or electrical medical devices.
• Prefer experience in a regulated environment such as ISO 13485.
• Prefer experience with Six Sigma and Lean principles.
• Prefer internal auditor certification in a regulated environment.
• 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.

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.

Minimum of a Bachelor's degree (BS) in engineering from a four‑year college or university; and three to five…