Production Documentation Specialist at Penumbra Inc

Salt Lake City, Utah, United States

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Not SpecifiedCompensation

Entry Level & New Grad, Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, PharmaceuticalsIndustries

Requirements

High School diploma or Associate degree
Minimum of 1 to 3 years of production systems experience in regulated device or pharmaceutical environments, or equivalent combination of education and experience
Strong written/verbal communication and organizational skills

Responsibilities

Receives and reviews production requests and assists in production control
Takes primary responsibility of printing Production DHRs and verifying accuracy in QAD
Reviews completed Device History Records with complete accuracy and attention to detail
Assists Production personnel with follow up on DHR discrepancies and Material Investigations
Provides lot status reports/updates during Master Schedule meetings
Accurately reconciles the finished and rejected parts
Verifies training on Device History Records
Works closely with multiple backend teams to assist in expediting Device History Records to make sterile load dates
Communicates effectively with supervisors to correct any errors or omissions in Device History Records or associated documents
Accurately enters Device History Record information into database
Scans, labels and files Device History Records correctly
Assists in various other Production Specialist tasks as needed
Adheres to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
Ensures other members of the department follow the QMS, regulations

Skills

Device History Records

QAD

Production Control

Quality Management System

Regulatory Compliance

Material Investigations

Data Entry

Document Review

Filing

Communication

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

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Parental Leave

Paid Vacation

Paid Sick Leave

Paid Holidays

Risks

Recent layoffs in the Immersive Healthcare division may indicate financial strain.

The EMBOLIZE trial could divert resources from core product lines.

Regulatory challenges in Europe may impact sales of new products like BMX81 and BMX96.

Differentiation

Penumbra offers a comprehensive range of neuro and peripheral vascular devices.

The company focuses on innovative solutions for stroke and neurovascular disease treatment.

Penumbra's global presence spans North America, Europe, Asia, and Australia.

Upsides

Growing demand for minimally invasive procedures aligns with Penumbra's product offerings.

The global neurovascular devices market is projected to grow at 8.5% CAGR until 2030.

Penumbra's European launch of BMX81 and BMX96 expands its market presence.

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