Sr. Quality Engineer

Bachelor’s degree in Engineering, a Life Science or related field with 5+ years of relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience.

Represent Quality Engineering on cross-functional teams – interfacing among multiple departments and teams such as Manufacturing, QC, R&D, Regulatory Affairs, Operations/Planning, and Marketing.
Evaluate, analyze, and continuously improve manufacturing processes, quality controls, and engineering systems for assigned product lines.
Own or review Engineering Change Orders on assigned projects and product lines.
Plan, design, and implement test/inspection methods, including test/inspection equipment, to achieve product quality control objectives.
Partner with suppliers to continually improve technical processes, reliability, and quality controls to meet Penumbra’s quality standards.
Take the lead on risk analysis and documentation.
Lead or participate in project teams – coordinating the quality efforts to meet project objectives.
Plan, schedule, and execute engineering project work to meet business and quality objectives.
Provide leadership and guidance to ensure assigned projects and product lines are compliant with the quality system and regulations.
Lead nonconforming report investigations and recommend appropriate corrective actions.
Identify the need for Corrective Action Preventative Action (CAPA). Initiate, implement, and close CAPAs.
Design experiments and tests, and apply statistical rationale to analyze, and interpret engineering test data.
Provide leadership and mentoring to more junior staff. May supervise junior engineers.

Advanced degree preferred
Experience in auditing, design review, sterilization, project management, and/or product development is highly desired.