Quality Engineer III

2 Months ago • 3 Years + • Manufacturing • $109,760 PA - $145,920 PA

Job Summary

Job Description

The Quality Engineer III at Penumbra will independently support Commercial Operations to ensure high-quality manufacturing of Class II/III interventional medical devices. Responsibilities include supporting manufacturing activities (inspections, NCRs, CAPAs, ECOs, etc.), performing failure analyses and defect investigations, executing continuous improvement efforts, supporting supplier activities (qualification, changes, SCARs), collaborating with other engineering departments and suppliers, developing manufacturing documentation, designing and improving test methods and equipment, recommending revisions to specifications, and providing guidance to junior engineers. The role requires familiarity with QSR, ISO, and other regulations, strong communication skills, and proficiency in MS Office Suite. The position involves work in office, laboratory, and cleanroom environments.
Must have:
  • Support manufacturing activities
  • Failure analysis & defect investigations
  • Continuous improvement efforts
  • Supplier activities support
  • Manufacturing documentation development
  • Test methods & equipment design/improvement
  • Guidance to junior engineers
  • QSR, ISO, & regulations knowledge
Good to have:
  • Leadership skills
Perks:
  • Collaborative teamwork environment
  • Generous benefits package (medical, dental, vision, life insurance, 401k, etc.)
  • Paid parental leave
  • Paid holidays and sick time
  • Vacation time

Job Details

General Summary
You will have an opportunity to identify and own high impact projects to life saving medical devices. In this opportunity, you will independently support Commercial Operations to ensure the high-quality manufacturing of Class II/III interventional medical devices. This position will provide work with problems of advanced scope where the analysis of situation or data requires a review of identifiable factors. Work with collaborative teams to exercise good judgment to determine appropriate quality actions, and communicate and implement quality objectives.
 
Specific Duties and Responsibilities
•Support Commercial Operations and Manufacturing activities such as Incoming/In-process/Final Inspections, NCRs, CAPAs, Engineering Change Orders, Control Chart Investigations, Deviation Authorizations, and Equipment sustaining activities.
•Support assigned manufacturing product lines and perform failure analyses and defect investigations as appropriate. 
•Execute and collaborate on Continuous Improvement efforts.
•Execute and support supplier activities such as Second Source Qualifications, Supplier Changes, and SCARs.
• Interface with other engineering departments within the company, and suppliers on quality related issues.
• Collaborate and/or help lead in the development of manufacturing documentation. 
• Design, improve and support Test Methods, Testing Equipment and TMVs. 
• Recommend revisions to specifications, acceptance criteria, and manufacturing documentation to improve quality of product and/or Manufacturing Operations.
• Provide guidance to junior Quality Engineers in support of departmental functions. 
• Perform responsibilities required by the Quality System and other duties as assigned or requested.  
•Ensure other members of the department follow the QMS, regulations, standards, and procedures.  
• Perform other work-related duties as assigned.
 
 
Position Qualifications
Minimum education and experience:
• Associate’s or Bachelor's degree in Engineering, a Life Science or a related field with 3+
years of quality engineering or relevant experience, preferably in a medical devices
environment, or equivalent combination of education and experience 
 
Additional qualifications: 
• Familiarity with QSR, ISO, and other applicable regulations and laws required 
• Excellent verbal, written, and interpersonal communication skills required 
• Leadership skills desired 
• Proficiency with MS Word, Excel, and PowerPoint required 
 
Working Conditions
• General office, laboratory, and cleanroom environments 
• Requires some lifting and moving of up to 25 pounds
• The employee is frequently required to stand, walk, sit, and reach with hands and arms, 
and to use a computer, sitting for extended periods. Specific vision abilities required by 
this job includes the ability to read, close vision, distance vision, color vision, peripheral 
vision, and depth perception.
 
Alameda, CA
Starting Base Salary is $109,760 to $145,920
 
The above statements are intended to describe the general nature and level of work being 
performed by people assigned to this classification. They are not intended to be construed as an 
exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
 
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 see 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 see Penumbra's AAP Policy Statement.
undefined

Similar Jobs

Tesla - Charging Operations Specialist, APAC Charging

Tesla

Taipei City, Taiwan (On-Site)
1 Month ago
Nisum - iOS Design Engineer A6079

Nisum

Hyderabad, Telangana, India (Hybrid)
5 Months ago
ByteDance - Tech Lead – CDN/PoP (Multiple Positions)

ByteDance

San Jose, California, United States (On-Site)
2 Months ago
Axon - Senior Revenue Accountant (Hybrid)

Axon

Scottsdale, Arizona, United States (Hybrid)
2 Months ago
Epic Games - Senior Director, Player Experience (EGS)

Epic Games

Cary, North Carolina, United States (On-Site)
1 Month ago
Taurus Contractors   - Civil and Structural Designer -Revit 3D - Data Center

Taurus Contractors

Gurugram, Haryana, India (On-Site)
7 Months ago
AGS - American Gaming Systems - Assembler I

AGS - American Gaming Systems

Oklahoma City, Oklahoma, United States (On-Site)
3 Months ago
Tesla - Industrial Engineer (m/w/d) - Gigafactory Berlin-Brandenburg

Tesla

Brandenburg, Germany (On-Site)
1 Month ago
Salesforce - Account Executive, DoD, Navy

Salesforce

McLean, Virginia, United States (On-Site)
4 Months ago
Trek - Seasonal Sales Associate

Trek

Omaha, Nebraska, United States (On-Site)
3 Months ago

Get notifed when new similar jobs are uploaded

Similar Skill Jobs

Meta - Manager, Recruiting Services & Operations

Meta

Menlo Park, California, United States (On-Site)
3 Months ago
Coursera - Director, FP&A

Coursera

India (Remote)
1 Month ago
The Walt Disney Company - Production Coordinator - Multiplatform

The Walt Disney Company

Burbank, California, United States (On-Site)
1 Month ago
IGT - Retail Experience Specialist

IGT

Indianapolis, Indiana, United States (On-Site)
2 Months ago
ION - NetSuite Helpdesk Administrator - 8604

ION

Noida, Uttar Pradesh, India (Hybrid)
4 Months ago
Paytm - Product Management - Senior Manager - Payments(Settlement)

Paytm

Bengaluru, Karnataka, India (On-Site)
3 Months ago
Starkflow - Operations Intern

Starkflow

Haryana, India (On-Site)
2 Months ago
Virtuos - 3D Environment Art Manager

Virtuos

Vietnam (On-Site)
4 Months ago
The Walt Disney Company - Local Tax Specialist

The Walt Disney Company

Serris, Île-de-France, France (On-Site)
1 Month ago
Nintendo - Brand Ambassador - Dallas, TX (Part-Time)

Nintendo

Dallas, Texas, United States (On-Site)
3 Months ago

Get notifed when new similar jobs are uploaded

Jobs in Alameda, California, United States

Hasbro - Director, Human Resources

Hasbro

Pawtucket, Rhode Island, United States (Hybrid)
3 Months ago
Trek - Store Manager

Trek

Ellicott City, Maryland, United States (On-Site)
3 Months ago
Meta - Copywriter

Meta

San Francisco, California, United States (On-Site)
3 Months ago
ByteDance - Software Engineer, Rendering Engine

ByteDance

San Jose, California, United States (On-Site)
3 Months ago
Mattel  Inc  - Director, Corporate Strategy & Development

Mattel Inc

California, United States (On-Site)
2 Months ago
The Walt Disney Company - Senior Network Operations Engineer

The Walt Disney Company

Las Vegas, Nevada, United States (On-Site)
3 Months ago
Mattel  Inc  - VP of IT - Global Delivery & Analytics

Mattel Inc

California, United States (On-Site)
2 Months ago
Warner Bros Discovery - Stagehand, Scenic Services (Temporary)

Warner Bros Discovery

Atlanta, Georgia, United States (On-Site)
3 Months ago
Tria Federal (Tria) - Data Scientist

Tria Federal (Tria)

Vienna, Virginia, United States (Remote)
6 Months ago
Axon - Head of Enterprise Marketing

Axon

Scottsdale, Arizona, United States (On-Site)
1 Month ago

Get notifed when new similar jobs are uploaded

Manufacturing Jobs

Assystems - Site Engineer- Electrical

Assystems

Bagalkote, Karnataka, India (On-Site)
4 Months ago
Intel Corporation - AMHS Software Engineering Manager - NM

Intel Corporation

Albuquerque, New Mexico, United States (On-Site)
1 Month ago
Intel Corporation - Utilities Procurement Manager

Intel Corporation

New Albany, Ohio, United States (Hybrid)
2 Months ago
Assystems - Ingénieur Systèmes Fluides Nucléaire Confirmé H/F

Assystems

Lyon, Auvergne-Rhône-Alpes, France (On-Site)
3 Months ago
Microsoft - Process Program Manager

Microsoft

San José, San José Province, Costa Rica (Hybrid)
1 Month ago
Assystems - Sr. Substation Design Engineer - Mechanical

Assystems

Gurugram, Haryana, India (On-Site)
3 Months ago
Fluence - Chief Mechanical Engineer

Fluence

Houston, Texas, United States (Hybrid)
4 Months ago
Fluence - Project Manager Belgium / Netherlands

Fluence

Amsterdam, North Holland, Netherlands (Hybrid)
4 Months ago
Assystems - Senior Primary Engineer

Assystems

Hyderabad, Telangana, India (On-Site)
3 Months ago
Assystems - Technical Author

Assystems

Derby, England, United Kingdom (On-Site)
3 Months ago

Get notifed when new similar jobs are uploaded