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Quality Assurance Specialist III

2 months ago

Chelmsford, Massachusetts, United States Akraya Inc. Full time
Position Title: Quality Engineer III

Job Overview:
We are in search of a seasoned Quality Engineer to spearhead our quality assurance initiatives within the life sciences sector. This role is essential for ensuring that our products and processes adhere to the highest standards of compliance and quality.

Key Responsibilities:
  • Lead comprehensive investigations into product and process deviations, employing various root cause analysis techniques to effectively resolve out-of-specification issues.
  • Ensure adherence to regulatory standards, manage customer feedback, and troubleshoot product-related challenges.
  • Develop and implement corrective and preventive actions (CAPAs), driving significant improvement projects and supporting ongoing 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 requirements.
  • Assist in internal and external audits, contribute to quality assurance functions, and uphold the site's compliance with ISO standards.

Essential Qualifications:
  • In-depth knowledge of quality management tools (e.g., FMEA, Six Sigma) and validation methodologies (IQ/OQ/PQ).
  • Extensive experience with ISO-9001:2015 and/or ISO 13485, compliance with DEA regulations, and various root cause analysis methodologies.
  • Strong proficiency in statistical analysis and technical documentation, coupled with excellent verbal and written communication skills in English.

This role operates during standard business hours, Monday to Friday, focusing on refining our quality processes and enhancing manufacturing excellence.

About Akraya:
Akraya is a distinguished IT staffing firm recognized for our unwavering commitment to excellence and a vibrant work culture. We have been honored as one of Inc's Best Workplaces 2024 and acknowledged by the San Francisco Business Journal and Glassdoor as one of the Best Places to Work in recent years.

Industry Leadership:
As a provider of staffing solutions for Fortune 100 companies, Akraya's accolades reinforce our leadership in the IT staffing industry. We connect candidates not just with outstanding job opportunities, but with workplaces that inspire.

Join Akraya:
Experience the Akraya difference and explore our open positions to find your ideal career path.