Sr Quality Engineer
About The Position
Our Work Matters At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make: As a Sr. Quality Engineer II, you will be a problem solver who takes initiative to address compliance and business-related issues. This role develops and supports continuous improvement loop systems for Quality ecosystems, including the creation and execution of Quality Engineering-related protocols. You will serve as a primary point of contact with external clients for Quality-related items and provide oversight, evaluation, and corrective action of assigned issues. This position assists in the gathering, interpretation, and application of statistical methods to various Production and Quality-related processes and communicates findings through reports, memos, files, and presentations. You will also serve as the person responsible for Quality Tracking System (TrackWise) records, including investigations, Corrective and Preventive Actions (CAPA), change management, and action items.
Requirements
- A bachelor’s degree in a scientific or engineering discipline is required.
- Minimum of 8 years of experience in a current Good Manufacturing Practice (cGMP) environment within a Food and Drug Administration (FDA)–regulated industry; a minimum of 6 years of experience is acceptable with a Master’s degree.
- Proficiency with computerized systems, including the Microsoft Office Suite.
- Strong client and customer relationship skills, with demonstrated ability to actively listen to client concerns and effectively coordinate internal support to address those concerns.
- Demonstrated ability to perform data analysis and interpret results to support quality and business decisions.
- Proven ability to manage multiple priorities in a fast-paced, regulated environment.
Nice To Haves
- Prior experience in aseptic isolator drug product manufacturing preferred.
- Experience within a Contract Development and Manufacturing Organization (CDMO) environment preferred.
Responsibilities
- Drive problem-solving and continuous improvement initiatives to enhance business processes while ensuring compliance with company procedures, quality standards, and applicable government regulations; identify and implement process capability, workflow, and compliance improvement projects.
- Represent Quality on product core teams and serve as the primary Quality interface with external clients, regularly engaging client Quality organizations to ensure alignment between Kindeva and customer expectations.
- Own assigned projects, providing end-to-end project management, task execution, and prioritization in collaboration with cross-functional partners, including Quality Assurance, Operations, Planning, and Laboratories.
- Analyze production and quality data across multiple manufacturing stages to assess process control and performance; compile and evaluate quality dat,a including gage Repeatability and Reproducibility (R&R) studies, process capability analyses, first article inspections, defect trending, and in-process or release testing data.
- Develop visual analytics, dashboards, and reports to support data-driven decision-making and facilitate continuous improvement discussions.
- Serve as Responsible Person, Reviewer, and/or Approver for change notifications, investigations, deviations, and action items; lead or support root cause analysis and coordinate corrective and preventive actions.
- Evaluate equipment and process issues, design testing strategies and investigation plans to identify root causes and implement effective solutions.
- Review, redline, and maintain controlled documents to ensure accuracy, compliance, and alignment with current processes and regulatory expectations.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
