Ken Kite Email & Phone Number

Maple Grove, Minnesota, United States

Quality data analytics responsible for improving awareness, visibility and communication of quality signals, initiatives, and objectives, and will supports departmental, functional, site, divisional and corporate quality goals, and priorities. Supports the development and enhancement of the Quality Systems to allow for fast, meaningful, and data driven response to quality signals.• Provides technical expertise in identifying, evaluating, developing, and implementing effective processes and systems solutions that meet business requirements.• Creates and implements enhancements to existing systems that standardize and automates ongoing processes, analysis, and communication of existing data • Serves as the liaison to customers by assessing and understanding user needs from non-technical users/customers.• Drives the data collection process, analyze for trends, and identify areas for system and process improvement.• Leads and manages projects associated with site quality initiatives to assure that the site’s interests are accurately and objectively represented from a quality perspective.

Maple Grove, Mn

A key member of the stent manufacturing support team partnering with representatives from the Manufacturing Engineering and Production functions. Has ownership of the stent finishing processes and takes the lead in addressing quality issues in a dynamic production environment. Manages relationships with downstream internal customers and supervising quality technicians.• Provides a leadership role in departmental and cross-functional engineering initiatives.• Supervises a team of quality technicians across 3 shifts.• Actively engage production teams to develop solutions.• Provides project direction, coaching, and mentoring for engineering and technical team personnel.• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.• Mentor for technical guidance for identifying and resolving quality issues.• Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.• Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.• Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

St. Joseph, Michigan

ACCOMPLISHMENTS: Managed and mentored 3-5 junior technicians to support diverse QA and validation requirements across R&D. Supported institutional growth by consulting with R&D and product management to ensure improvements to functionality and performance of analyzers in accordance with ISO 9001. Established SOP supporting QA in fast-paced lab and clinical research settings and consulting with R&D and product management. Collaborated with C-suite by providing feedback and recommendations to R&D and product management regarding improvements to functionality, performance, and usability of analyzers & the software interface in accordance with ISO 9001. Developed efficient department by writing custom software applications to automate laboratory procedures, data analysis, reporting and departmental administrative duties.  Developed internal laboratory management system to store, query and analyze data. Leveraged resources through expert budget and vendor management. Applied 6 sigma approach to continuous improvement.HONORS: Promoted to establish & lead newly created validation department from specialist-level position.Supervised and trained specialists to provide validation services throughout organization as well as to develop infrastructure for much-needed department including developing business and technical processes. Analyzed new assays and upgraded equipment to ensure software was debugged and properly functioning. Investigations included: Instrument Stability | Spectral Quality | Isotopic Fidelity | Mass Accuracy | Accelerated System Stress Testing. Notable new instrument analysis included Pegasus HRT (High-Resolution GCxGC TOF-MS) and Pegasus BT (Ultra-Sensitive Full Scan GCxGC TOF-MS).

St. Joseph, Michigan

ACCOMPLISHMENTS: Reduced training expenses by 97.5% by designing and building a web-based training portal for independent learning and creating an interactive webinar. Increased quality and efficiency by writing Python based applications to automate >1K spreadsheets which identified previously unknown problems and reduced administrative strain. Improved customer satisfaction by 64% by designing, documenting, and implementing a customer and education and instrument installation support process as well developed quality assurance tests to verify repaired equipment was fully operational. Created new training curriculum to address the needs of our most advanced customers which encompassed 11 separate courses.Provided onsite consultation on the use and application of our GCxGC TOF-MS Chemical Analyzers. Provided chemical application and software support via: site visits, webinar, remote PC access, phone, and e-mail. Drafted training materials which included manuals, slide decks, and videos.

Roswell, Ga

ACCOMPLISHMENTS: Developed protocols utilizing Python, SQL, & VBA coding to allow Research and Development to automate the monitoring of quality control testing. Led a clinical field study using preproduction lactate sensors in a hospital environment. Increased efficiency by developing software to automate data mining, processing, and reporting procedures. Improved quality assurance by managing a broad spectrum of R&D analyses in the development of new blood sensors in accordance with ISO 13485 & ISO 9001 requirements. Prepared and submitted a highly restrictive, FDA 510(k) premarket notification for novel lactate blood sensor.  Created R&D & QC protocols, SOPs, analyzed, interpreted data, and composed summary reports in compliance with GMP, GLP and CLIA guidelines.Participated in the research and development phases of the novel lactate blood sensor including creating protocols, interpretation, data, and writing reports for C-suite. In addition, collaborated with software engineers to validate and verity device performance. Designed VBA automated spreadsheets streamlining the analysis of highly complicated data compilation & analysis procedures performed by QC technicians.

Greater Atlanta Area

 Designed, constructed, and calibrated an ultra-high vacuum chemical reactor to study the photocatalytic decomposition of water on a zirconia nanoparticle to generate molecular hydrogen. Incorporated Quadrupole Mass Spectrometer, UV-vis and IR detectors into the chemical reactor design for enhanced analytic capabilities. Performed reproducible methods for vacuum deposition of gas phase water molecules onto zirconia nanoparticles to catalyze the cracking of water to produce H2.  Served as safety captain with responsibilities of maintaining update and accurate chemical inventory, ensuring proper disposal of chemicals, and organizing MSDS sheets.

Master’S Degree, Physical Chemistry

Activities and Societies: Chemistry Club• Published Master’s thesis titled “Photosensitizer Triplet-State and Singlet Oxygen Quantum.

Bs, Chemistry