Quality Engineer II

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.

2.

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.

3.

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.

4.

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 mak...