Sr Quality Assurance Engineer

• Serve as a subject matter expert on key areas of the Quality System (e.g. sterilization, environmental controls, inspection, & testing).*

• Own and lead one or more quality systems, driving continuous improvement and ensuring compliance with internal standards and regulatory requirements.*

• Mentor and lead junior engineers, providing technical guidance and professional development. May supervise junior engineers.*

• Support or lead qualification and validation activities for products, equipment, and facilities, ensuring readiness for production and compliance with standards.*

• Act as a technical problem-solver, proposing and implementing robust solutions to complex quality and engineering challenges.*

• Lead or participate in cross-functional project teams - coordinating the quality efforts to meet project objectives.

• Plan, schedule, and execute engineering project work to meet business and quality objectives.

• Design experiments and tests, and apply statistics to analyze and interpret engineering test data

• Partner with suppliers to continually improve technical processes, reliability, and quality controls to meet Penumbra's quality standards.

• Lead Nonconforming Report (NCR) investigations and identify appropriate corrective actions.

• Identify the need for Corrective Action Preventative Action (CAPA). Initiate, implement, and close CAPAs.

• Continuously assess and improve internal controls and system documentation to support regulatory compliance and operational excellence.*

• Own or review Engineering Change Orders (ECOs) on assigned projects and areas of responsibility.

• Support FDA, FDB, and notified body audits and inspections*

• Act as a liaison with internal departments, customers, and suppliers on quality-related matters.*

• Provide training and guidance to peers and staff on quality regulations, best practices, and QMS requirements.*

• Ensure full compliance with the Quality Management System (QMS) and applicable domestic and international regulations, standards, and procedures.*

• Perform other work-related duties as assigned.

• 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

• Strong oral, written and interpersonal communication skills

• High degree of accuracy and attention to detail

• Proficiency with Microsoft Word, Excel, PowerPoint and other standard office tools

• Experience in auditing, sterilization, environmental controls, operations, and/or project management is highly desired

• General office, laboratory, and cleanroom environments.

• Potential exposure to blood-borne pathogens.

• Requires some lifting and moving of up to 25 pounds.

• The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods.

• Specific vision abilities required by this job include ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.

• A collaborative teamwork environment where learning is constant, and performance is rewarded.

• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.

• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

Penumbra