Be an early applicantLess than 25 applicantsPosted by Agency
Advantage Technical ยท 2 days ago
Sr. Quality Specialist
Los Angeles, CA
Contract
Onsite
Senior Level
$35/hr - $40/hr
3+ years exp
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Responsibilities
Provide rigorous assessment of non-conformance activities and documentation to ensure compliance with quality management systems and regulatory requirements.
Offer guidance, support, and mentorship to non-conformance process owners on best practices, record content, and software tools.
Support Material Review Board (MRB) and senior leadership with metrics and reporting on non-conformance processes.
Participate in MRB activities, conduct internal audits, and contribute to the improvement of procedures, software, and training programs.
Interpret governmental regulations, agency guidelines, and internal policies to ensure compliance with non-conformance processes.
Support internal and external audits and inspections related to non-conformance records and processes.
Perform other duties as assigned.
Qualification
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Required
Bachelor's degree and 3+ years or Master's degree with 1+ years in a quality, manufacturing, or leadership role (preferably in Quality Management Systems)
Experience working with CAPA, complaints, and nonconformances
Experience in medical device, pharmaceutical, IVD and/or a comparable regulated environment
Influence management skills; ability to work constructively across all functions of the organization as well as with external customers, notified bodies, regulatory agencies, and competent authorities
Project management skills
CAPA documentation systems experience (e.g. CATSWeb, MasterControl, Trackwise,, etc.)
Experience reviewing CAPA, complaint, nonconformance documentation (preferably as an independent reviewer)
Strong written and verbal communication skills
Ability to educate people in the CAPA program
Experience with quality tools and process improvement techniques
Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
Strong analytical and decision-making skills
Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and CAPA requirements in general
Benefits
Medical, dental, and vision plans
Pre-tax savings plans
Pre-tax parking and commuter plans
Supplemental health and welfare plans
Retirement savings plan
Employee assistance program
Pet insurance
Paid holidays
Short-term incentives
Paid time off
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10,001+ employees
H1B Sponsorship
Advantage Technical 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
2022 (4)
2021 (10)
2020 (47)
Funding
Current Stage
Late StageCompany data provided by crunchbase
