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Senior Quality Assurance Engineer

2 months ago

Chelmsford, Massachusetts, United States Akraya Inc. Full time
Position: Quality Engineer III
Contract Type: W2 Only
Location: Onsite
Compensation: $30 - $34 Per Hour

JOB RESPONSIBILITIES:
We are looking for a skilled Quality Engineer with a robust background in life sciences to spearhead our quality engineering initiatives. The selected candidate will play a crucial role in ensuring product and process compliance at the highest standards. Key responsibilities include:
  • Leading investigations into process and product deviations, utilizing various root cause analysis techniques to effectively resolve out-of-specification issues.
  • Ensuring adherence to regulatory requirements, managing customer feedback, and addressing product-related challenges.
  • Implementing and assessing the effectiveness of corrective and preventive actions (CAPAs), while driving complex improvement projects to foster continuous enhancement across the organization.
  • Conducting statistical analyses for monitoring processes and products, as well as leading risk assessments and validation activities in accordance with quality and regulatory benchmarks.
  • Supporting both internal and external audits, contributing to quality assurance efforts, and ensuring the site's quality systems align 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, DEA compliance, and root cause analysis techniques.
  • 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 quality processes and enhancing manufacturing excellence.
ABOUT AKRAYA:

Akraya is a distinguished IT staffing firm recognized for our dedication to excellence and a vibrant work culture. We have been honored as one of Inc's Best Workplaces 2024 and have received accolades from the San Francisco Business Journal and Glassdoor.

Leading the IT Staffing Industry

As a staffing solutions provider for Fortune 100 companies, Akraya's accolades reinforce our leadership in the IT staffing sector. We aim to connect you not just with great job opportunities, but with a workplace that inspires.

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