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Penumbra, Inc. · 2 hours ago

Quality Monitoring & Improvement Specialist I

Alameda, CA

Full-time

Onsite

Entry Level

$32/hr - $43/hr

1+ years exp

Penumbra, Inc. is a global healthcare company focused on innovative therapies, designing and manufacturing life-saving products. The Quality Monitoring & Improvement Specialist I role involves supporting the Quality Management System processes, ensuring compliance with quality standards through organizing meetings, tracking documentation, and assisting with audits.

Medical Device

H1B Sponsor Likely

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. 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

Qualification

Quality Management SystemCorrectivePreventive ActionsNonconformance ReportsData analysisMedical device experienceMS Word proficiencyMS Excel proficiencyMS PowerPoint proficiencyBilingual Spanish/EnglishInterpersonal communicationAttention to detailOrganizational skills

Required

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

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

Preferred

Bilingual Spanish/English fluency is a plus

Medical device, pharmaceutical, biotech, or other regulated industry experience desired

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 (30)

2024 (42)

2023 (48)

2022 (43)

2021 (36)

2020 (26)