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Lead Quality Control Engineer - Bioburden & Endotoxin | Quality Control in Quality Assurance J1

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Lead Quality Control Engineer - Bioburden & Endotoxin

Location:
Boulder, CO
Description:

The Water Technologies and Solutions, Analytical Instruments product line business has an opportunity for a Lead Quality Control Engineer in Boulder, CO. Position Purpose 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. 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. Create critical manufacturing and QC laboratory operating procedures and approve all changes Participate as a core team member on new product development and introduction teams. Knowledge, Skills & Abilities Strong data analytical skills 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, Biomedical Engineering, Microbiology, Biochemistry, Biology, Chemical Engineering or related degree 5+ years of Life Sciences Quality Engineering or Manufacturing Engineering or relevant 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 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. Our ground-breaking endotoxin analyzer is the latest addition to our expanding analytical instruments portfolio. We strive to provide not only superior technology and design, but also outstanding quality, service, and application support. Why You’ll Love Working Here! In diversity lies strength - We strive to be a workplace that is inclusive and empowers people to contribute their best Recognition and rewards for your hard work and achievements Opportunity for new challenges - We are growing and love to promote from within An excellent leadership team and a collaborative culture that values innovation 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: 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: $102,000 - $118,000 annually Annual Incentive Plan Bonus: 10% Medical, Dental, & Vision Insurance Starting Day 1! Life Insurance Paid Time Off Paid Holidays Parental Leave 401(k) Plan Flexible Spending & Health Saving Accounts AD&D Insurance Disability Insurance Tuition Reimbursement 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.
Company:
Veolia Water Technologies & Solutions
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Lead Quality Control Engineer - Bioburden & Endotoxin is a Quality Assurance Quality Control Job at Veolia Water Technologies & Solutions located in Boulder CO. Find other listings like Lead Quality Control Engineer - Bioburden & Endotoxin by searching Oodle for Quality Assurance Quality Control Jobs.