200+ applicants
AbbVie · 6 days ago
Quality Engineer IV
Dublin, CA
Full-time
Onsite
Senior Level
$148K/yr - $158K/yr
5+ years exp
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Responsibilities
Ensure quality standards for manufacturing, servicing, warehousing, & distribution of Zeltiq manufactured products.
Lead & oversee quality operations, drive process improvements, & collaborate with cross-functional teams to maintain compliance & enhance overall quality of the product.
Work in a quality engineering FDA regulated Medical device manufacturing environment.
Serve as quality leader on the production line, providing day-to-day oversight & guidance to manufacturing activities.
Utilize knowledge of QSR & ISO 13485.
Act as primary quality contact for production, ensuring production line’s compliance with quality standards.
Review and approve changes made to product and processes, validation/qualification protocols, and reports.
Write reports, data analysis, and business correspondence.
Collaborate with internal customers and suppliers to investigate, document, review, and approve non-conformances, failure analysis reports, and deviations.
Foster effective relationships and integration with other departments and suppliers, collaborating on quality-related activities and initiatives as needed.
Utilize mathematical concepts such as probability and statistical inference to define problems, collect data, establish facts, and draw valid conclusions.
Initiate and update Quality Procedures for Quality Operations functions.
Ensure product compliance with specifications through the implementation of inspection criteria, procedures, and training.
Perform duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements.
Establish and maintain quality metrics to monitor performance and identify areas for improvement.
Identify and lead projects and initiatives aimed at enhancing the quality system and driving continuous improvement across the production line.
Coach and develop junior team members.
Conduct internal audits to assess compliance with quality standards.
Qualification
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Required
Bachelor’s degree or foreign academic equivalent in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Chemical Engineering, or a related field of study with 5 years of related experience
Master’s degree in aforementioned fields with 1 year of related experience
At least 1 year of experience in working in a quality engineering FDA regulated Medical device manufacturing environment
At least 1 year of experience in writing reports, data analysis, and business correspondence
At least 1 year of experience in utilizing mathematical concepts such as probability and statistical inference to define problems, collect data, establish facts, and draw valid conclusions
At least 1 year of experience in performing duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term and long-term incentive programs
Company
AbbVie
AbbVie is a pharmaceutical company that discovers, develops, and markets medicines.
10,001+ employees
H1B Sponsorship
AbbVie 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
Trends of Total Sponsorships
2023 (155)
2022 (299)
2021 (194)
2020 (197)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-21IPO· nyse:ABBV
Leadership Team
Robert Michael
President and Chief Operating Officer
A
Azita Saleki Gerhardt
Senior Vice President, Operations
Recent News
2024-06-05
News is my Business
2024-06-03
Company data provided by crunchbase
