Quality Control Lead

2 weeks ago

Boulder CO, United States Veolia North America Full time

Veolia Water Technologies & Solutions (VWTS) is a worldwide leader in water recovery, treatment, and reuse. We design, supply, and service a range of water systems and monitoring equipment in industries ranging from pharmaceutical to food and beverage applications, and from microelectronics ultrapure water to municipal water and industrial wastewater treatment. We are one of the world's leading manufacturers of total organic carbon (TOC) analyzers and corresponding certified reference materials. We strive to provide not only superior technology and design, but also outstanding quality, service, and application support.
The Water Technologies and Solutions, Analytical Instruments product line business has an opportunity for a Lead Quality Control Engineer in Boulder, CO.
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 within our bioburden analyzer and endotoxin consumables. 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.
Proficient with data analysis, data analysis tools (e.g. JMP), and other software tools (e.g. Salesforce and SAP)
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
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. 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.
Create critical manufacturing and QC laboratory operating procedures and approve all changes
Strong data analytical skills
Ability to present complex data to a variety of audiences for understanding
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
S. degree in an Engineering or Biology discipline, preferably, Bio-Chemical Engineering, Biomedical Engineering, Microbiology, Biochemistry, Biology, Chemical Engineering or related degree
~5+ years of Life Sciences Quality Engineering or Manufacturing Engineering or relevant experience

Experience in a pharmaceutical or microbiology position with experience in bacterial endotoxin or bioburden testing.
In diversity lies strength - We strive to be a workplace that is inclusive and empowers people to contribute their best
At all levels of the organization, we recognize talent and want to help you build your sustainable career
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:
~ Medical, Dental, & Vision Insurance Starting Day 1
~ Paid Holidays
~ Flexible Spending & Health Saving Accounts
~ Disability Insurance
~ Tuition Reimbursement

S. immediately; H-1B visa) for this opportunity****
As an inclusive company, Veolia is committed to diversity and gives equal consideration to all applications, without discrimination.

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