QC Continuous Improvement (Medical Devices) - Intellectt INC

Job Title : QC Continuous Improvement
Location : Charlotte, NC

Must Have:

• Data sets, data manipulation, assessments on improvement from GMP manufacturing and QC
• Ability to look at data manipulation, look at SPC going into lean 6 sigma processing
• Knowledge of manufacturing GMP
• Ingenuity, being able to develop processes
• Having lead a team
• Cycle time reduction and key capstone projects
• IDEX processing and quantifiable data
• Creating infrastructure and logbooks within excel and helping migrate to new systems (using Python, mini tab and other stat programming)
• Justification around processes and why they're needing to be streamlined
• Statistical process control for GMP manufacturing

Description (please note that the more important information is in the "must have column" Supervisory Responsibilities:

• Manages staffing, overseeing hiring, training, and development, while coordinating scheduling, assignments, and workflow.
• Reviews HR platform for accurate employee time logging and approval, maintains records, and manages lab retains.
• Provides guidance, training, and developmental opportunities to QC method development analysts, emphasizing safety. Conducts periodic reviews and offers regular feedback.
• Facilitates cross-training among QC staff and develops training programs for staff.

General Duties/Responsibilities:

• Acts as a liaison on all issues related to QC/Production and QC/raw material supplier interface.
• Supports QC lab daily operations, serves as a backup to the QC supervisor, and ensures the lab is kept clean and orderly in a 5S state.
• Ensures all instruments and analytical equipment are calibrated, maintained, and validated, including coordinating instrument troubleshooting and repair.
• Performs OOS investigations for all production and customer-related non-conformances and performs quality testing as needed to support production or confirm test results.
• Designs necessary experiments, conducts Gage R&R studies, and drives method development, ensuring continuous improvement of QC daily workflow.
• Performs root cause analysis investigations, drives CAPA for operations, and proactively reviews batch records and instructions to lead improvement initiatives.
• Researches, evaluates, and vets new instrumentation, and manages the NIR database, releasing models for use.
• Assists with quality order, D365, and Whiteboard issues, and assists in maintaining ISO 9001:2015, EFFCI, and GMP certifications for the QC lab.
• Assists with inventory management, facilitates the ordering process, and generates work orders as needed for items requiring repair or replacement in the lab.
• Implements Lean Six Sigma methodologies to enhance efficiency and reduce waste within the QC department and drives innovation in QC practices through the adoption of emerging technologies and analytical methods.
• Collaborates with cross-functional teams to integrate quality control standards company-wide and champions a culture of safety and environmental responsibility.
• Develops and maintains the Quality Management System (QMS) to ensure compliance with industry standards, including overseeing the validation and implementation of new laboratory information management systems (LIMS).
• Leads the preparation and readiness for external quality audits, coordinates responses to audit findings, and negotiates contracts and manages relationships with third-party vendors and service providers.
• Establishes key performance indicators (KPIs) to track quality objectives, reports on QC performance to senior management, and prepares and delivers comprehensive training modules on quality standards, procedures, and best practices.
• Manages projects related to continuous improvement in QC Lab and Operations, including testing by special request.

Education and Experience:

Bachelor's degree Chemistry, Engineering, or related field required; Master's degree preferred
Three to five years of experience in related field with supervisory experience required.