Sr Quality Assurance Engineer at Penumbra Inc

Alameda, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

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
Ability to work in general office, laboratory, and cleanroom environments with potential exposure to blood-borne pathogens
Requires some lifting and moving of up to 25 pounds
Ability to stand, walk, sit, reach with hands and arms, use a computer for extended periods, and specific vision abilities including ability to read and close vision

Responsibilities

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 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

Skills

Key technologies and capabilities for this role

Quality SystemsSterilizationEnvironmental ControlsInspectionTestingQualificationValidationStatisticsNCR InvestigationsCorrective ActionsSupplier Management

Questions & Answers

Common questions about this position

What are the minimum education and experience requirements for this role?

A Bachelor's degree in engineering, a life science, or related field with 5+ years of relevant experience, including experience in quality assurance, is required.

What key responsibilities does this position involve?

The role includes serving as a subject matter expert on quality systems like sterilization and inspection, owning and leading quality systems, mentoring junior engineers, leading qualification activities, and supporting audits and compliance.

Is there a salary range mentioned for this position?

This information is not specified in the job description.

What is the work arrangement or location policy for this role?

This information is not specified in the job description.

What experience makes a candidate stand out for this Senior Quality Assurance Engineer role?

Candidates with 5+ years of relevant experience, expertise in quality systems like sterilization and validation, leadership in CAPA and NCR investigations, and the ability to mentor juniors and drive continuous improvement will be strongest.

Penumbra Inc

Develops medical devices for vascular conditions

About Penumbra Inc

Penumbra Inc. specializes in creating medical devices aimed at treating neurovascular and peripheral vascular conditions. Their products, such as the Penumbra System and the Indigo System, are designed for use in hospitals and clinics, helping healthcare professionals address issues like stroke and other vascular diseases. These devices work by providing advanced tools for interventions in neurology and vascular surgery, allowing for effective treatment options. Unlike many competitors, Penumbra focuses specifically on these specialized areas, ensuring their products are tailored to the needs of medical professionals in these fields. The company's goal is to continuously improve and innovate their medical devices to enhance patient care and support healthcare providers in delivering effective treatments.

Alameda, CaliforniaHeadquarters

2004Year Founded

$116.7KTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees