Quality Compliance Auditor

4 Months ago • 3 Years + • Manufacturing

Job Summary

Job Description

Job Details

As a member of Penumbra’s internal audit team, you will play a key role in ensuring that Penumbra's lifesaving products meet the highest standards of safety and effectiveness, and in instilling a quality mindset throughout the company. To do this, you will communicate and implement quality objectives internally and evaluate Penumbra’s Quality Management System against applicable standards and regulations. You will also assist in the logistics for training of select internal groups on a variety of quality auditing topics.

What You’ll Work On
• Participate in quality system internal audits including development of plans, reports, opening and closing meetings, collection, and analysis of data; provide input regarding compliance status.
• Assist in the development of plans for the specific audited area, referencing the SOP and connecting with coordinating with schedules.
• Schedule the audit opening meeting with the established audit plan and coordinating the audit schedule meetings as well as participating in the overview of the audit experience and process.
• Support the generation of metrics to measure internal audit compliance success and support improvement opportunities.
• Stay current on industry requirements and trends related to quality compliance in the medical device industry.
• Assist with the review of internal audit responses, corrective action, and effectiveness checks.
• Follow up with responses with internal audit response owners to ensure responses are received in a timely manner.
• Coordinate training sessions and webinars for relevant quality topics and upcoming changes to standards or regulations.
• Maintain records that support the internal audit program.
Assist in writing standard operating procedures and work instructions and performing engineering change orders.

What You Contribute
• A Bachelor’s degree, preferably in life sciences or engineering with 3+ years of quality systems experience in a regulated medical device or pharmaceutical environment with at least 1+ year in quality system auditing, or an equivalent combination of education and or demonstrated experience.
• Lead Auditor certification preferred.
• Medical device, pharmaceutical, biotech, or other regulated industry experience
• Knowledge of FDA 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), MDR and MDSAP
• Excellent oral, written, and interpersonal communication skills
• High degree of accuracy and attention to detail
• Proficiency with MS Word, Excel, and PowerPoint
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

Working Conditions
General office, production, warehouse, laboratory, and controlled environments. Willingness and ability to work on site. May have business travel from 0% to10%. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 15 pounds. Must be able to move between buildings and floors. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. Must be able to read, prepare emails, and produce documents and spreadsheets. Must be able to move within the office and access file cabinets or supplies, as needed. Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

Annual Base Salary Range:  $75,000 - $145,000 / year
We offer a competitive compensation package plus a benefits and equity program, when applicable.  
Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.  
 
 
What We Offer
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes 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, and paid sick time in compliance with applicable law(s).
 
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
 
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
 
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
 
For additional information on Penumbra’s commitment to being an equal opportunity employer, please Penumbra's AAP Policy Statement.

What We Offer
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes 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, and paid sick time in compliance with applicable law(s).
 
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
 
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
 
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
 
For additional information on Penumbra’s commitment to being an equal opportunity employer, please Penumbra's AAP Policy Statement.

undefined

Similar Jobs

Onward Search - Sales Development Representative (Real Estate)

Onward Search

Pennsylvania Furnace, Pennsylvania, United States (On-Site)
3 Months ago
Playtech - Portal WebMaster Coordinator

Playtech

Sofia, Sofia City Province, Bulgaria (On-Site)
2 Weeks ago
The Walt Disney Company - Senior Financial Analyst

The Walt Disney Company

Burbank, California, United States (On-Site)
1 Week ago
Haleon - Product Manager Cross-Product Integration (Finance Systems)

Haleon

Bengaluru, Karnataka, India (Hybrid)
3 Months ago
Amber - Financial Analyst

Amber

Bogota, Colombia (On-Site)
5 Months ago
Tesla - 25 Guns Taskforce Engineer

Tesla

Brandenburg, Germany (On-Site)
1 Week ago
Assystems - Buyer

Assystems

Derby, England, United Kingdom (On-Site)
3 Months ago
Assystems - Project Engineering Manager – Substation (Head of Electrical Engineering)

Assystems

Gurugram, Haryana, India (On-Site)
3 Months ago
HP - Manufacturing Technician

HP

Penang, Malaysia (On-Site)
1 Month ago
Assystems - PROCESS  ENGINEER

Assystems

Bengaluru, Karnataka, India (On-Site)
4 Months ago

Get notifed when new similar jobs are uploaded

Similar Skill Jobs

Netflix - Staff Product Designer, Member Experience - Personalization

Netflix

United States (Hybrid)
3 Months ago
PwC - Expert | FP&A

PwC

Warsaw, Masovian Voivodeship, Poland (Hybrid)
4 Months ago
NVIDIA - CAD Layout Design Engineer

NVIDIA

Bengaluru, Karnataka, India (Hybrid)
1 Month ago
Evolution - Payroll Accountant

Evolution

Medellín, Antioquia, Colombia (On-Site)
9 Months ago
ByteDance - Creator Operations Intern (Philippines)

ByteDance

Taguig, Metro Manila, Philippines (On-Site)
1 Month ago
Funko - Sr. Manager, Compensation

Funko

Everett, Washington, United States (On-Site)
3 Months ago
Scientific Games  - Product Innovation & Development Specialist

Scientific Games

Alpharetta, Georgia, United States (On-Site)
1377 Years ago
NVIDIA - DFT Engineer - Hardware

NVIDIA

Bengaluru, Karnataka, India (Hybrid)
1 Month ago
Dynamics - Emergency Management Specialist

Dynamics

(Remote)
2 Months ago
Unity - Data Analyst

Unity

Tel Aviv-Yafo, Tel Aviv District, Israel (On-Site)
5 Months ago

Get notifed when new similar jobs are uploaded

Jobs in Alameda, California, United States

Paypal - Machine Learning Engineer

Paypal

San Jose, California, United States (Hybrid)
4 Months ago
Rockstar Games - Senior Full Stack Engineer (C#/React)

Rockstar Games

Andover, Massachusetts, United States (On-Site)
5 Months ago
Tencent - Game Research & Development Intern, Engine Research

Tencent

Los Angeles, California, United States (On-Site)
8 Months ago
Salesforce - Account Executive, Data Cloud

Salesforce

San Francisco, California, United States (On-Site)
4 Months ago
Warner Bros Games - Social Programmer, Hockey (Temporary)

Warner Bros Games

New York, New York, United States (Hybrid)
2 Months ago
Fabric - Applied Researcher, Cryptography Hardware

Fabric

Chicago, Illinois, United States (Remote)
4 Months ago
Alphasense - Senior Customer Lifecycle Marketing Manager

Alphasense

Remote, Oregon, United States (Remote)
3 Weeks ago
Onward Search - Streaming Coordinator

Onward Search

Los Angeles, California, United States (On-Site)
5 Days ago
NVIDIA - Senior System Software Engineer - Triton Inference Server

NVIDIA

California, United States (Remote)
1 Month ago
Netflix - Sr. Gameplay Engineer, Games Experience Engineering

Netflix

Los Gatos, California, United States (Remote)
3 Months ago

Get notifed when new similar jobs are uploaded

Manufacturing Jobs

Tesla - Manufacturing Engineer, Battery Cell

Tesla

Brandenburg, Germany (On-Site)
1 Week ago
Intel Corporation - Full Stack Software Development Engineer

Intel Corporation

San José, San José Province, Costa Rica (Hybrid)
2 Months ago
Tesla - Operations Manager, Drive Unit and Battery Pack

Tesla

Brandenburg, Germany (On-Site)
1 Week ago
Logitech - CMF Engineering trainee

Logitech

Suzhou, Jiangsu, China (On-Site)
4 Months ago
Trek - Sales Associate - Part Time

Trek

Fairfax, Virginia, United States (On-Site)
1 Week ago
Fluence - HSE (Health, Safety & Environment) Advisor

Fluence

Adelaide, South Australia, Australia (On-Site)
3 Months ago
Nissan - Analista Control de Producción (Analista Recibidor)

Nissan

Jiutepec, Morelos, Mexico (On-Site)
4 Months ago
Tesla - New Product Introduction Engineer, Vehicle

Tesla

Brandenburg, Germany (On-Site)
1 Week ago
Trek - Sales Associate

Trek

The Woodlands, Texas, United States (On-Site)
3 Months ago
Fluence - Commissioning Engineer_New Markets

Fluence

Amsterdam, North Holland, Netherlands (Remote)
4 Months ago

Get notifed when new similar jobs are uploaded

About The Company

Roseville, California, United States (On-Site)

Roseville, California, United States (On-Site)

Alameda, California, United States (On-Site)

Alameda, California, United States (On-Site)

Berlin, Berlin, Germany (Hybrid)

View All Jobs

Get notified when new jobs are added by Penumbra

Level Up Your Career in Game Development!

Transform Your Passion into Profession with Our Comprehensive Courses for Aspiring Game Developers.

Job Common Plug