Quality Assurance Specialist

1 day ago


Billerica, Massachusetts, United States Nuclera Full time

About Nuclera

Nuclera is a pioneering biotechnology company that has revolutionized the field of protein expression and purification. Our cutting-edge technology, the eProtein Discovery System, has made proteins accessible to life science researchers, accelerating breakthroughs in human health.

Job Summary

We are seeking an experienced Quality Engineer to join our Quality Group in the US. As a Quality Engineer, you will play a critical role in ensuring compliance with our Quality Management System (QMS) requirements. Your responsibilities will include monitoring and testing product quality, identifying issues, and recommending solutions related to supply chain components, materials, and internal manufacturing processes.

Key Responsibilities

  • Implement effective quality control and assurance solutions related to incoming materials and manufactured products.
  • Drive robust documentation related to QMS requirements to carry out audits, root cause investigations, risk assessments, and Failure Mode and Effects Analysis (FMEA).
  • Initiate and contribute to Change Requests for the Change Control Board, providing coherent and clearly presented data.
  • Lead Statistical Process Control (SPC) activities that support continual improvement to processes.
  • Drive Preventative Maintenance and Calibration programs.
  • Support sustaining a 5S/CANDO workplace.
  • Support other Quality department tasks as necessary.

Requirements

  • 3+ years of experience in a quality engineer role.
  • Strong understanding of statistical analysis techniques.
  • Six Sigma Green or Black belt certification.
  • Collaborative synergy through R&D, Manufacturing, and Facilities.
  • Experienced in incoming materials testing and controls.
  • Familiar with ISO 9001 Quality Management Systems functions and documentation.
  • Experienced in Quality Audits.
  • Experienced in selecting and using appropriate Lean quality tools.
  • Interpersonal, communication, and presentation skills.
  • Critical thinker and problem-solving skills.
  • Organization and time management skills.

Desirable Qualifications

  • Knowledge of semiconductor processes.
  • Knowledge of Clean Room automated manufacturing processing equipment.
  • Familiarity with supplier requirements following QMS.

What We Offer

  • Competitive salaries.
  • Incentive stock options.
  • A comprehensive benefits package that includes medical, dental, vision, and life insurance.
  • Short- and long-term disability insurance.
  • 401(k) retirement plan.
  • 25-day annual holiday allowance.
  • Investment in professional development and learning.
  • Fresh fruit, tea, coffee, and snacks in the office.
  • Organized summer events for staff and their families.


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