Senior Quality Assurance Engineer
2 weeks ago
Essential Skills:
Quality Control, Product Assessment, CAPA analysis, DFMEA & PFMEA, ISO/FDA/IVDR/QSR
Position:
Senior Quality Assurance Engineer
Contract Type:
W2 only
Compensation:
$56.50 Per Hour
KEY RESPONSIBILITIES:
We are seeking a proficient Quality Assurance Engineer with a focus on medical devices to guarantee that our offerings adhere to all quality benchmarks and regulations throughout the design and development phases.
This position entails spearheading quality assurance initiatives for new product development, which includes crafting and executing testing strategies and protocols, facilitating product design enhancements, and overseeing quality aspects throughout the product lifecycle.
The ideal candidate will collaborate closely with internal teams, including research and development, operations, and supply chain, to refine product designs and processes.
JOB REQUIREMENTS:
Lead and assist in new product development endeavors, ensuring adherence to quality management frameworks and regulatory requirements. Address quality challenges, implement process enhancements, and update risk assessments related to operations. Oversee pre- and post-production design assurance and quality engineering tasks. Evaluate, endorse, and verify the precision of validation protocols, reports, and supplier quality. Facilitate the resolution of quality assurance challenges, direct CAPA investigations, and support quality engineering for product assessments.
Core Qualifications:
A Bachelor’s degree with at least 7 years of experience in medical device quality assurance. Strong proficiency in product/process validation, software validation, test method validation, and employing risk management methodologies. Outstanding documentation, process orientation, and analytical capabilities with a talent for converting data into actionable insights.
Work Schedule:
M-F 8am-5pm, Fully onsite
ABOUT AKRAYA:
Akraya is a distinguished IT staffing firm recognized for our dedication to excellence and a positive workplace culture.
Celebrated as the #1 Best Place to Work in Silicon Valley and a Glassdoor Best Places to Work (2023 & 2022), Akraya emphasizes a culture of inclusivity and nurtures a sense of belonging for all team members.
We provide staffing solutions for Fortune 100 companies, and our industry accolades reinforce our leadership position in the IT staffing sector.
Join us at Akraya to explore your career potential.-
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