Quality Assurance Engineer

2 weeks ago

Billerica, Massachusetts, United States Nuclera Full time
Job Overview

Nuclera, a pioneering biotech firm based in Cambridge, UK, with significant operations in Boston, USA, is at the forefront of advancing rapid protein expression and purification technologies. Our innovative eProtein Discovery™ System is designed to make proteins readily accessible, facilitating groundbreaking advancements in human health and empowering life science researchers.

We are seeking a dedicated Quality Engineer to bolster our Quality Group in the US. This position reports directly to the Quality Group Lead and plays a crucial role in ensuring adherence to Quality Management System (QMS) standards. The Quality Engineer will be responsible for monitoring and evaluating product quality, identifying potential issues, and proposing effective solutions concerning supply chain components, materials, and internal manufacturing processes. The ideal candidate will possess a hands-on approach and a keen attention to detail, thriving in a dynamic environment where timely delivery is paramount.

Key Responsibilities:

  • Developing and implementing robust quality control and assurance measures for incoming materials and manufactured products.
  • Creating and maintaining comprehensive documentation related to QMS requirements to facilitate audits, root cause analyses, risk assessments, and Failure Mode and Effects Analysis (FMEA).
  • Initiating and participating in Change Requests for the Change Control Board, ensuring data is presented clearly and coherently.
  • Leading Statistical Process Control (SPC) initiatives to promote continuous improvement in processes.
  • Overseeing Preventative Maintenance and Calibration programs.
  • Contributing to the maintenance of a 5S/CANDO workplace environment.
  • Assisting with various tasks within the Quality department as needed.

Qualifications:

Essential:

  • A minimum of 3 years of experience in a quality engineering capacity.
  • Proficient understanding of statistical analysis methodologies.
  • Possession of a Six Sigma Green or Black belt certification.
  • Ability to foster collaborative relationships across R&D, Manufacturing, and Facilities.
  • Experience in testing and controlling incoming materials.
  • Familiarity with ISO 9001 Quality Management Systems and associated documentation.
  • Experience conducting Quality Audits.
  • Skilled in selecting and utilizing appropriate Lean quality tools.
  • Strong interpersonal, communication, and presentation abilities.
  • Critical thinking and problem-solving aptitude.
  • Excellent organizational and time management skills.

Desirable:

  • Knowledge of semiconductor manufacturing processes.
  • Familiarity with Clean Room automated manufacturing equipment.
  • Understanding of supplier requirements in accordance with QMS.

Benefits:

What We Provide:

Alongside competitive salaries, we offer a comprehensive benefits package that includes:

  • Incentive stock options.
  • Medical, dental, vision, and life insurance coverage.
  • Short- and long-term disability insurance.
  • 401(k) retirement savings plan.
  • 25 days of annual leave.
  • Investment in professional development and learning opportunities.
  • Access to fresh fruit, tea, coffee, and snacks in the workplace.
  • Organized summer events for staff and their families.

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