Quality Assurance Engineer
1 week ago
Nuclera is a venture-backed biotechnology firm based in Cambridge, UK, with substantial operations in Boston, USA. We are at the forefront of making rapid protein expression and purification accessible at the benchtop level through our innovative eProtein Discovery™ System. Our mission is to enhance human health and empower life science researchers by providing easy access to target proteins.
Position Summary:
We are seeking a dedicated Quality Assurance Engineer to support 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) requirements. The Quality Assurance Engineer will monitor and evaluate product quality, identify issues, and propose solutions concerning supply chain components, materials, and internal manufacturing processes.
Key Responsibilities:
- Implement effective quality control and assurance strategies for incoming materials and manufactured products.
- Develop and maintain comprehensive documentation related to QMS requirements, facilitating audits, root cause analyses, risk assessments, and Failure Mode and Effects Analysis (FMEA).
- Initiate and contribute to Change Requests for the Change Control Board, ensuring data is presented clearly and coherently.
- Lead Statistical Process Control (SPC) initiatives to promote continuous improvement in processes.
- Drive Preventative Maintenance and Calibration programs.
- Support the maintenance of a 5S/CANDO workplace.
- Assist with various tasks within the Quality department as needed.
Qualifications:
Essential:
- Minimum of 3 years of experience in a quality engineering role.
- Strong grasp of statistical analysis techniques.
- Six Sigma Green or Black Belt certification.
- Ability to collaborate effectively across R&D, Manufacturing, and Facilities.
- Experience in testing and controlling incoming materials.
- Familiarity with ISO 9001 Quality Management Systems and related documentation.
- Experience conducting Quality Audits.
- Proficient in selecting and utilizing appropriate Lean quality tools.
- Strong interpersonal, communication, and presentation skills.
- Critical thinking and problem-solving abilities.
- Excellent organizational and time management skills.
Desirable:
- Knowledge of semiconductor processes.
- Familiarity with Clean Room automated manufacturing equipment.
- Understanding of supplier requirements in relation to QMS.
Benefits:
We offer a competitive salary along with a comprehensive benefits package that includes:
- Incentive stock options.
- Medical, dental, vision, and life insurance.
- Short- and long-term disability insurance.
- 401(k) retirement plan.
- 25 days of annual vacation.
- Investment in professional development and learning opportunities.
- Fresh fruit, tea, coffee, and snacks available in the office.
- Organized summer events for staff and their families.
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