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Quality Assurance Specialist
2 months ago
Nuclera, a pioneering biotech company, is seeking a highly skilled Quality Engineer to join their Quality Group in the US. This role reports directly to the Quality Group Lead and is responsible for ensuring compliance with Quality Management Systems (QMS) requirements.
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/Clean As You Go (CANDO) workplace.
- Support other Quality department tasks as necessary.
- 3+ years of experience in a quality engineer role.
- Strong understanding of statistical analysis techniques.
- Six Sigma Green or Black belt.
- Collaborative synergy through Research and Development, 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.
- Knowledge of semiconductor processes.
- Knowledge of Clean Room automated manufacturing processing equipment.
- Familiarity with supplier requirements following QMS.
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.
What We Offer- 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.
