Senior Quality Assurance Engineer
2 weeks ago
Job Title: Senior Quality Assurance Engineer
Contract Type: W2 Only
Location: Chelmsford, MA (Onsite)
Compensation: $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 optimal product and process adherence. The selected candidate will be tasked with performing 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, thereby significantly influencing our capacity to fulfill and surpass client expectations.
JOB REQUIREMENTS:
- Lead and conduct investigations into process and product deviations, employing various root cause analysis techniques to effectively manage out-of-specification conditions.
- Ensure compliance with DEA regulations, adeptly manage customer grievances, and troubleshoot product-related issues.
- Implement and assess the effectiveness of CAPAs, leading intricate improvement initiatives and supporting continuous enhancement efforts across the organization.
- Conduct statistical analyses for monitoring processes and products, and lead risk assessments and validation activities in accordance with quality and regulatory standards.
- Assist in internal and external audits, contribute to quality assurance efforts, and maintain the site's quality systems in alignment with ISO standards.
- In-depth knowledge of quality tools (e.g., FMEA, Six Sigma) and validation principles (IQ/OQ/PQ).
- Extensive experience with ISO-9001:2015 and/or ISO 13485, DEA compliance, and root cause analysis methodologies.
- Proficient in statistical analysis and technical documentation, with exceptional verbal and written communication skills in English.
ABOUT AKRAYA:
Akraya is a recognized IT staffing firm celebrated for our commitment to excellence and a positive workplace culture. We have been honored 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 today
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