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Penumbra, Inc. · 2 months ago

Production Documentation Specialist

Salt Lake City, UT

Full-time

Onsite

Entry Level

$20/hr - $28/hr

1+ years exp

Penumbra is a global healthcare company focused on innovative therapies, and they are seeking a Production Documentation Specialist to ensure compliance with procedures and regulatory requirements. The role involves managing Device History Records, assisting in production control, and ensuring accuracy in documentation.

Medical Device

H1B Sponsor Likely

Responsibilities

Receives and reviews production requests and assists in production control

Take primary responsibility of printing Production DHRs and verifying accuracy in QAD

Review completed Device History Records with complete accuracy and attention to detail

Assist Production personnel with follow up on DHR discrepancies and Material Investigations

Provide lot status reports/updates during Master Schedule meetings

Accurately reconcile the finished and rejected parts

Verify training on Device History Records

Work closely with multiple backend teams to assist in expediting Device History Records to make sterile load dates

Communicate effectively with supervisors to correct any errors or omissions in Device History Records or associated documents

Accurately enter Device History Record information into database

Scan, label and file Device History Records correctly

Assist in various other Production Specialist tasks as needed

Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures

Ensure other members of the department follow the QMS, reg

Qualification

Production systems experienceDevice History RecordsQADQuality Management SystemCommunication skillsOrganizational skills

Required

High School diploma or Associate degree with a 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 required

Benefits

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

Paid sick time in compliance with applicable law(s)

Company

Penumbra, Inc.

Glassdoor3.3

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies.

Founded in 2004

Alameda, CA, US

1001-5000 employees

http://www.penumbrainc.com

H1B Sponsorship

Penumbra, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (36)

2024 (42)

2023 (46)

2022 (43)

2021 (36)

2020 (26)