CIVCO Medical Solutions · 11 hours ago
Quality Engineer II
Coralville, IA
Full-time
Hybrid
Mid Level
3+ years expCIVCO Medical Solutions is focused on improving quality, engineering, and production systems. The Quality Engineer II role involves coordinating projects to support new product development, ensuring compliance with regulatory standards, and driving continuous improvement initiatives.
BiotechnologyHealth CareManufacturingMedical Device
Responsibilities
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)
Qualification
Required
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
Strong knowledge of FDA, ISO 13485, and other applicable regulatory requirements
Hands-on experience with risk management, product validation, and cross-functional collaboration
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
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
Preferred
Experience with electrical devices or electrical medical devices
Experience in a regulated environment such as ISO 13485
Experience with Six Sigma and Lean principles
Internal auditor certification in a regulated environment
Company
CIVCO Medical Solutions
CIVCO Medical Solutions has over 35 years of experience offering cutting-edge medical technology to a diverse group of medical professionals.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase