Lead Quality Engineer – Bioburden & Endotoxin
| Company | Veolia |
|---|---|
| Location | Boulder, CO, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | |
| Experience Level | Senior, Expert or higher |
Requirements
- Proficient with data analysis, data analysis tools (e.g. JMP), and other software tools (e.g. Salesforce and SAP)
- Ability to prioritize assignments, handle multiple tasks, and innovate continuous improvement in a fast-paced life science industry
- Microbiology and life science knowledge and understanding
- Leadership skills with the ability to lead indirect teams and provide guidance to others
- Ability to drive continuous improvement with minimal direct oversight
- Understanding of manufacturing and new product introduction processes
- Problem solving, attention to detail and emotional intelligence
- Collaboration, team building, and ability to lead change
- Knowledge of compliance and regulatory requirements for ISO 9001 and Life Science industry
- Strong data analytical skills and ability to excel in online quality systems
- Ability to present complex data to a variety of audiences for understanding
- Ability to solve complex problems in a timely manner
- In-depth knowledge of microbiology including bacterial endotoxin and bioburden testing methods
- Ability to manage changing priorities in a fast-paced product development and manufacturing environment
- Excellent oral and written communication skills to communicate complex data
- Experience in International Quality Standards, particularly ISO 9001:2015 and ISO 13485
- Awareness and working knowledge of cGMP standards
- Ability to mentor others.
Responsibilities
- Lead cross-functional quality improvement teams ensuring quality activities and plans are formulated and followed and key quality metrics are met
- Identify and lead application of quality tools (e.g. RCA, FMEA, CAPA) on internal manufacturing processes, customer support processes, supplier processes, and continuous improvement.
- Drive process validation, monitoring and control at critical suppliers and internally using data analysis software tools (e.g. JMP) and conduct Design of Experiments for critical product parameters.
- Present supplier and customer data to various internal and external audiences.
- Facilitate and review quality activities for parts approval, supplier manufacturing processes (control plans, assembly instructions) and confirm process capability.
- Investigate internal or customer product quality problems, determine root cause, gather and analyze data and implement corrective/preventive actions for non-conformance. Author Failure Analysis Reports with Product Management.
- Participate as a core team member on new product development and introduction teams.
- Oversee the scheduling, training, and operations of the Eclipse QC Laboratory. This can include maintaining appropriate controlled documentation and Laboratory Investigation Reports.
Preferred Qualifications
- Experience in a pharmaceutical or microbiology position with experience in bacterial endotoxin or bioburden testing.
- Internal and/or external auditing to ISO 9001 or ISO 13485 standards