Quality Engineer

Nuclera is a venture-backed biotech company headquartered in Cambridge, UK with significant operations in Boston, USA. Our company is the pioneer in bringing rapid protein expression and purification screens to the benchtop. We make proteins accessible through the eProtein Discovery™ System. Through our technology we accelerate breakthrough improvements in human health and empower life science researchers with easy access to target proteins.

Nuclera is looking for an enthusiastic Quality Engineer to join and support their Quality Group located in the US. This role reports directly to the Quality Group Lead.  In this role, the Quality Engineer ensures compliance to the QMS requirements by monitoring and testing product quality, identifying issues, and recommending solutions related to supply chain components, materials and internal manufacturing processes. This role requires someone who can be hands-on, with a good eye for detail. The role will also require rigorous data collection and strong statistical analysis skills. This role suits someone who is accustomed to working in a fast paced environment where delivery to tight timelines is essential.

About the role:

• Implementing effective quality control and assurance solutions related to incoming materials and manufactured products 
• Driving robust documentation related to QMS requirements to carry out audits, root cause investigations, risk assessments and FMEA

• Initiating and contributing to Change Requests for the Change Control Board, providing coherent and clearly presented data

• Leading SPC activities that support continual improvement to processes.

• Driving Preventative Maintenance and Calibration programs

• Supports sustaining a 5S/CANDO workplace
• Supports other Quality department tasks as necessary

Requirements

Essential:

• 3+ years of experience in a quality engineer role
• Strong understanding of statistical analysis techniques
• Six Sigma Green or Black belt
• 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 selecting and using appropriate Lean quality tools.
• Interpersonal, communication and presentation skills.
• Critical thinker and problem-solving skills
• Organization and time management skills

Desirable:

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

Benefits

What we offer

In addition to competitive salaries, we offer a range of benefits including:

• 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