Quality Assurance Engineer
1 week ago
Nuclera, a pioneering biotech firm based in Cambridge, UK, with substantial operations in Boston, USA, is at the forefront of advancing rapid protein expression and purification technology. Our innovative eProtein Discovery™ System is designed to make proteins readily accessible, facilitating significant advancements in human health and empowering life science researchers.
We are seeking a dedicated Quality Engineer to enhance our Quality Group in the US. This position is essential for ensuring adherence to Quality Management System (QMS) standards by evaluating and testing product quality, pinpointing issues, and proposing effective solutions concerning supply chain elements, materials, and internal manufacturing procedures. The ideal candidate will possess a meticulous eye for detail and a hands-on approach. This role demands rigorous data collection and robust statistical analysis capabilities, suited for a dynamic environment where timely delivery is crucial.
Key Responsibilities:
- Developing and implementing efficient quality control and assurance strategies for incoming materials and manufactured products.
- Creating comprehensive documentation related to QMS requirements to facilitate audits, root cause analyses, risk assessments, and Failure Mode and Effects Analysis (FMEA).
- Initiating and contributing to Change Requests for the Change Control Board, ensuring data is presented clearly and coherently.
- Leading Statistical Process Control (SPC) initiatives that foster continuous improvement in processes.
- Overseeing Preventative Maintenance and Calibration programs.
- Promoting and maintaining a 5S/CANDO workplace environment.
- Assisting with various tasks within the Quality department as required.
Qualifications:
Essential:
- Minimum of 3 years of experience in a quality engineering capacity.
- Proficient understanding of statistical analysis methodologies.
- 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 associated documentation.
- Experience conducting Quality Audits.
- Proficient in selecting and utilizing relevant 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 manufacturing processes.
- Familiarity with Clean Room automated manufacturing equipment.
- Understanding of supplier requirements in relation to 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.
- Short- and long-term disability insurance.
- 401(k) retirement plan.
- 25 days of annual leave.
- Investment in professional development and training.
- Fresh fruit, tea, coffee, and snacks available in the office.
- Organized summer events for staff and their families.
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