Quality Monitoring & Improvement Specialist I at Penumbra Inc

Alameda, California, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor's degree preferably in engineering, life sciences, or a related field with 1+ years of quality systems experience in a regulated medical device or pharmaceutical environment, or an equivalent combination of education and experience
Spanish/English fluency is a plus
Medical device, pharmaceutical, biotech, or other regulated industry experience desired
Strong oral, written, and interpersonal communication skills
High degree of accuracy and attention to detail
Proficiency with MS Word, Excel, and PowerPoint
Ability to create basic charts and graphs for data analysis in Excel
Excellent organizational, interpersonal, and verbal and written communication skills, with high attention to detail and the ability to deliver quality outputs under supervision
Ability to excel in a fast-paced environment
Ability to stand, walk, sit, reach with hands and arms, use a computer for extended periods, and specific vision abilities (reading, close vision, distance vision, color vision, peripheral vision, depth perception)

Responsibilities

Organizes and facilitates board meetings with guidance to review assigned QMS process documentation, giving regular status updates
Communicates with NCR/CAPA/DA owners to obtain status updates or provide reminders about upcoming due dates
Maintains and updates NCR/CAPA/DA tracking systems
Prioritizes routing QMS process documentation for approvals and follows up with approvers if response is not received in a reasonable timeframe
Collaborates and communicates cross-functionally with teams including, but not limited to, Manufacturing Engineering, Quality Engineering, Regulatory Affairs, R&D, and Production
Assists with data compilation for monthly trending meetings
Receives data requests (charts, graphs, etc.), and implements the changes with guidance/support
Supports management during internal and external audits, with guidance/support
Reviews quality records associated with the QMS process to ensure accuracy with the approved format and standards
Provides basic guidance on the assigned QMS process(es)
Maintains control and access of quality records for the assigned QMS process
Cross trains on other QMS processes and provides backup and support when needed

Skills

Key technologies and capabilities for this role

QMSCAPANCRDAAuditsRegulatory ComplianceData CompilationExcelCross-functional CollaborationBoard Meetings

Questions & Answers

Common questions about this position

What education and experience are required for this role?

A Bachelor's degree preferably in engineering, life sciences, or a related field with 1+ years of quality systems experience in a regulated medical device or pharmaceutical environment, or an equivalent combination of education and experience is required.

What key skills are needed for the Quality Monitoring & Improvement Specialist I position?

Strong oral, written and interpersonal communication skills, high degree of accuracy and attention to detail, proficiency with MS Word, Excel, and PowerPoint, and ability to create basic charts and graphs in Excel are essential.

Is remote work available for this position?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this Quality Monitoring & Improvement Specialist I role?

Candidates with experience in medical device, pharmaceutical, or regulated industries, Spanish/English fluency, and the ability to excel in a fast-paced environment with excellent organizational skills stand out.

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