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Senior Quality Assurance Engineer
2 months ago
Job Title: Senior Quality Assurance Engineer
Contract Type: W2 Only
Location: Onsite
Compensation Range: $30 - $34 Per Hour
JOB RESPONSIBILITIES:
We are in search of a seasoned Quality Assurance Engineer with a robust background in life sciences to spearhead our quality assurance initiatives, ensuring the utmost level of product and process adherence. The successful candidate will take charge of conducting comprehensive root cause investigations, executing effective corrective and preventive measures, and steering the site towards ongoing enhancement by refining critical quality parameters. This position is crucial in upholding our dedication to quality, regulatory adherence, and operational excellence, thus directly influencing our capability to fulfill and surpass customer expectations.
KEY RESPONSIBILITIES:
- Lead and conduct thorough investigations into process and product discrepancies, utilizing various root cause analysis techniques to effectively address out-of-specification scenarios.
- Ensure comprehensive compliance with regulatory standards, adeptly manage customer feedback, and troubleshoot product-related challenges.
- Implement and assess the effectiveness of corrective and preventive actions, leading intricate improvement initiatives and supporting continuous enhancement efforts across the organization.
- Perform statistical evaluations for process and product oversight, and lead risk assessments and validation tasks in accordance with quality and regulatory guidelines.
- Assist in internal and external audits, contribute to quality assurance activities, and maintain the organization's quality systems in alignment with ISO standards.
ESSENTIAL QUALIFICATIONS:
- In-depth knowledge of quality methodologies (e.g., FMEA, Six Sigma) and validation principles (IQ/OQ/PQ).
- Extensive experience with ISO-9001:2015 and/or ISO 13485, regulatory compliance, and root cause analysis methodologies.
- Proficient in statistical analysis and technical documentation, with exceptional verbal and written communication skills in English.
This role operates Monday to Friday, 8:00 am - 5:00 pm, with a focus on refining our quality processes and enhancing our manufacturing excellence.
ABOUT AKRAYA:
Akraya is a distinguished IT staffing firm consistently acknowledged for our commitment to excellence and a positive workplace culture. Recognized 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 fosters 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 Akraya and embark on your journey towards a fulfilling career.