Jobs for People with MS: National MS Society

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 s

Job 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 ommunication 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

Qualifications

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