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.)

1.

New Product Development:


*
+ 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.

 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, 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.

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 make quality decisions.

5.

Leadershi...