We are seeking a Quality Engineer II to drive compliance, risk management, and continuous improvement across our product lifecycle.

Requirements

In-depth knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP
Strong understanding of risk management principles, including ISO 14971 and PFMEA
Familiarity with statistical tools and methodologies such as Six Sigma, Statistical Process Control (SPC), and Design of Experiments (DOE)
Proficient in Quality Management Systems (QMS), data analysis tools, and enterprise software systems
Proven ability to lead Nonconforming Events (NCE) investigations and CAPA teams
Strong technical writing skills for preparing and reviewing technical reports, validation documentation, and quality records
Analytical skills to compile, interpret, and act on quality system metrics and product quality data
Ability to facilitate design transfers and manage seamless product transitions between sites during New Product Introduction (NPI)
Proficient in developing and maintaining process FMEAs throughout the production lifecycle
Strong communication and collaboration skills to work effectively across teams and with stakeholders

Benefits

We are seeking a Quality Engineer II to drive compliance, risk management, and continuous improvement across our product lifecycle.

In-depth knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP
Strong understanding of risk management principles, including ISO 14971 and PFMEA
Familiarity with statistical tools and methodologies such as Six Sigma, Statistical Process Control (SPC), and Design of Experiments (DOE)
Proficient in Quality Management Systems (QMS), data analysis tools, and enterprise software systems
Proven ability to lead Nonconforming Events (NCE) investigations and CAPA teams
Strong technical writing skills for preparing and reviewing technical reports, validation documentation, and quality records
Analytical skills to compile, interpret, and act on quality system metrics and product quality data
Ability to facilitate design transfers and manage seamless product transitions between sites during New Product Introduction (NPI)
Proficient in developing and maintaining process FMEAs throughout the production lifecycle
Strong communication and collaboration skills to work effectively across teams and with stakeholders