Lead Quality Engineer (Bioburden & Endotoxin)

Location: Boulder
Posted on: June 23, 2025

Job Description:

Company Description Veolia Group is a global leader in environmental services, operating across all five continents with nearly 218,000 employees. Specializing in water, energy, and waste management, Veolia Group designs and implements innovative solutions for decarbonization, depollution, and resource regeneration, supporting communities and industries in their ecological transformation. Within this framework, Veolia's Water Technology Business brings together a dedicated team of experienced professionals committed to tackling the world's most complex challenges related to water scarcity, quality, productivity, and energy. Together, we pursue a shared mission to create a more sustainable future. Job Description The ideal candidate will have a strong manufacturing and quality background, is self-motivated, strategic and team focused. This is an exciting and unique role, where the candidate will take ownership of quality systems, compliance, and data analysis for revolutionary technologies. Proven communication and team building skills are essential to success. We are looking for a candidate who can be a key contributor and leader on a talented and diverse team to meet both quality and customer expectations. This role will primarily focus on Bioburden and Endotoxin. Key Characteristics 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 Duties & 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. Qualifications Knowledge, Skills & Abilities 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. Education & Experience Required: B.S or M.S. degree in an Engineering or Biology discipline, preferably, Bio-Chemical Engineering, Bio-Medical Engineering, Microbiology, Biochemistry, Biology, Chemical Engineering or related degree 5 years of relevant life sciences Quality Engineering or Manufacturing Engineering experience Preferred: 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 Additional Information At Veolia, we realize diverse teams make smarter decisions, deliver better results, and build stronger communities. We're an organization that champions diversity and inclusion at every rung of the ladder and are proud to be an equal opportunity workplace. Because our people are our greatest assets, we also offer competitive compensation and benefits that include: Compensation - The salary range is tied to the market for similarly benchmarked roles. The range is not an absolute, but a guide, and offers will be based on the individual candidate's knowledge, skills, experience, and market conditions, as well as internal peer equity. Depending upon all the preceding considerations for the final selected individual candidate, the offer may be lower or higher than the stated range: $$90,000 - $115,000 annually This role also includes a 10% annual incentive plan (AIP). Medical, Dental, & Vision Insurance Starting Day 1! Life Insurance Paid Time Off Paid Holidays Parental Leave 401(k) Plan - 3% default contribution plus matching! Flexible Spending & Health Saving Accounts AD&D Insurance Disability Insurance Tuition Reimbursement This position is expected to stay open until June 20, 2025. Please submit your application by this date, to ensure consideration. Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. The Company reserves the right to modify this information at any time, subject to applicable law. Applicants are required to be eligible to lawfully work in the U.S. immediately; employer will not sponsor applicants for U.S. work authorization (e.g. H-1B visa) for this opportunity VWTS does not accept unsolicited resumes from external recruiting firms. All vendors must have a current and fully executed MSA on file before submitting candidates. Any unsolicited resumes and candidate profiles will be deemed the property of VWTS, and no fee will be due. As an inclusive company, Veolia is committed to diversity and gives equal consideration to all applications, without discrimination.

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