Kyle Onjukka
Quality Assurance Supervisor | Regulatory Compliance Expert | Process Improvement Specialist
Lewisville,TX
Summary
Collaborative, solutions-oriented quality assurance and regulatory compliance professional with over 15 years of experience in the medical device, pharmaceutical, and biotechnology industries. Expert in developing, implementing, and managing quality management systems (QMS), ensuring regulatory compliance (FDA, ISO 13485, ISO 9001), and driving process improvements for efficiency and cost reduction. Strong communicator, with a proven ability to lead cross-functional teams, manage audits, and improve quality operations. Passionate about continuous learning and fostering a culture of excellence in quality
Overview
16
16
years of professional experience
Work History
Quality Assurance Supervisor
Wiley X
Frisco, TX
01.2024 - 09.2024
- Spearheaded cross-departmental collaboration to address and resolve product quality issues, ensuring adherence to regulatory standards.
- Developed and implemented robust QA policies, procedures, and standards, optimizing internal processes.
- Led quality audits, ensuring compliance with ISO 9001 and ISO 17025 standards.
- Identified and implemented process improvements that reduced costs and enhanced customer satisfaction.
- Mentored and guided staff on best practices in quality assurance and compliance.
Quality Assurance Specialist
Steri-Tek
Lewisville, TX
10.2022 - 10.2023
- Streamlined communication and collaboration by revising standard operating procedures (SOPs), enhancing overall process efficiency.
- Provided expert consultation to management on QA standards and regulatory requirements.
- Assisted in developing training materials for quality assurance topics, ensuring staff readiness and compliance.
- Maintained and updated quality assurance protocols, ensuring adherence to industry best practices.
Quality Assurance Specialist
Microconsult Inc.
Addison, TX
09.2021 - 08.2022
- Designed and maintained quality control systems to monitor and improve production processes.
- Conducted root cause analysis to identify and resolve quality issues, enhancing overall product quality.
- Implemented new methods to measure process efficiency, resulting in better tracking of performance metrics.
Quality Engineer Consultant
Dechra Pharmaceutical
Fort Worth, Texas
04.2021 - 08.2021
- Led corrective and preventive action (CAPA) efforts, addressing non-conformities and ensuring continuous improvement.
- Established and monitored key performance indicators (KPIs) for quality objectives, aligning with business goals.
- Performed data analysis to uncover the root causes of quality issues and developed actionable corrective plans.
Various Contract Positions
Various
Dallas-Fort Worth, TX
08.2016 - 03.2021
- Served in various contract roles, including Regulatory and Quality Assurance Associate, Health and Safety Consultant, Document Analyst, and Regulatory Affairs & QA Manager.
- Provided expertise to ensure compliance with FDA, ISO, and GMP standards
Quality Assurance Consultant
Integrated DNA Technologies
Wilsonville, Oregon
08.2014 - 09.2015
- Trained and mentored staff on quality control processes and adherence to ISO 13485 and FDA regulations.
- Championed the adoption of new technologies to enhance productivity and improve quality assurance processes.
- Ensured adherence to QA procedures and collaborated with management on resolving major quality issues.
Medical Device Consultant
Nephron Pharmaceuticals
Columbia, South Carolina
01.2015 - 07.2015
- Led staff delegations, developed work schedules, and managed workloads to meet critical deadlines.
- Collaborated with R&D to research and implement solutions to improve product quality and reduce customer complaints.
- Prepared detailed reports for senior management and regulatory agencies, ensuring compliance and transparency.
Environmental Health and Safety Specialist
Acumed LLC, A Colson
Hillsboro, Oregon
01.2009 - 08.2013
- Developed and implemented comprehensive safety policies and procedures, reducing workplace hazards.
- Conducted safety inspections, ensuring compliance with environmental regulations and best practices.
- Oversaw the proper disposal of hazardous waste, ensuring adherence to local, state, and federal regulations.
Education
B.S. - Biology
Internship: Channeling protein research for heart drug design (Pfizer)
Skills
- Quality Leadership
- Regulatory Compliance
- Gap Analysis
- Risk Management
- Quality improvements
- Quality Assurance
- Root Cause Analysis
- Quality Metrics and Tracking
- Process Improvement
- Project Management
- Quality Management Systems
- Consulting
Accomplishments
- Successfully increased project savings, reduced manufacturing costs, and shortened product release times through effective implementation of LIMS.
- Managed the establishment of a new medical device, including FDA 510(k) approval, ensuring market readiness and regulatory compliance.
- Spearheaded the modernization and standardization of Quality Management Systems across multiple organizations, leading to significant process efficiencies and compliance improvements.
- Delivered expert guidance during ISO, FDA, DEA, and other regulatory audits, ensuring successful audit outcomes with minimal findings.
Focal Points
- Quality Leadership
- Audit Preparedness
- Regulatory Compliance
- Gap Analysis
- Risk Management
- ISO 9001, 17025, 13485
- Root Cause Analysis
- Quality Metrics and Tracking
- Process Improvement
- Project Management
- Quality Management Systems
- Procedure and Training Establishment
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse
Timeline
Quality Assurance Supervisor - Wiley X
01.2024 - 09.2024
Quality Assurance Specialist - Steri-Tek
10.2022 - 10.2023
Quality Assurance Specialist - Microconsult Inc.
09.2021 - 08.2022
Quality Engineer Consultant - Dechra Pharmaceutical
04.2021 - 08.2021
Various Contract Positions - Various
08.2016 - 03.2021
Medical Device Consultant - Nephron Pharmaceuticals
01.2015 - 07.2015
Quality Assurance Consultant - Integrated DNA Technologies
08.2014 - 09.2015
Environmental Health and Safety Specialist - Acumed LLC, A Colson
01.2009 - 08.2013
Portland State University - B.S., Biology
Similar Profiles
Marcus EllisMarcus Ellis
Data Entry / Front Desk Receptionist at Wiley XData Entry / Front Desk Receptionist at Wiley X
Misty GregsonMisty Gregson
Licensed Practical Nurse at Wiley Christian Retirement CommunityLicensed Practical Nurse at Wiley Christian Retirement Community
Gabriel JimenezGabriel Jimenez
Accounting Associate at Wiley CPAs and AdvisorsAccounting Associate at Wiley CPAs and Advisors
Keziah RothenbergerKeziah Rothenberger
Senior Regional Director at Covenant Home Care LLCSenior Regional Director at Covenant Home Care LLC
Kendall NarramoreKendall Narramore
Caregiver at Ray Of Sunshine Senior CareCaregiver at Ray Of Sunshine Senior Care