Ronald Rink
Warrington,PA
Summary
Quality assurance professional with proven record in driving quality initiatives and maintaining high standards. Known for fostering team collaboration and delivering consistent results in dynamic environments. Skilled in developing quality control protocols and problem-solving under changing conditions.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Quality and Regulatory Manager
Boekel Scientific
01.2015 - 12.2024
- Maintain companies ISO 13485 certification
- Management Representative
- Responsible for companies Corrective and Preventive Action, Document Control and Internal Audit systems.
- Coordinate product testing for regulatory conformance, assuring product quality to these standards.
- Develop and document product testing protocol used for product testing.
- Assist customers with quality problems, troubleshooting to determine correction and provide assistance for repair of equipment.
- Recommended improvements to processes.
Quality Assurance Manager
First Article Inc.
03.2010 - 12.2014
- Developed ISO 13485 Quality Management System for a medical device machining and assembly company.
- Responsible for maintaining QMS system including Management Representative,
- Liaison for required customer, registrar and FDA audits as required.
- Enhanced product quality by implementing comprehensive QA processes and procedures.
- Assessed product quality by monitoring quality assurance metrics, reports and dashboards.
- Trained team members on quality assurance principles, fostering a culture of accountability and high performance.
Education
High School Diploma -
William Tennent
Warminster, PA06-1979
Skills
- 30 years ISO experience
- Auditing expertise
- Regulatory research
- Regulatory submissions
- Global regulatory compliance
- Risk management
- Requests for information
- Technical writing
Microsoft Office
Label Design / Management
Accomplishments
- Successfully implement UDI (Unique Device Identifier) system for Medical Devices.
- Developed and documented company On Time Delivery and Product Return data collection system used as company Quality Objective.
- Supervised Repair department staff members for the warranty repair of product.
Certification
- ASCQ Certified Mechanical Inspector
- ISO Lead Auditor
Timeline
Quality and Regulatory Manager
Boekel Scientific
01.2015 - 12.2024
Quality Assurance Manager
First Article Inc.
03.2010 - 12.2014
- ASCQ Certified Mechanical Inspector
- ISO Lead Auditor
High School Diploma -
William Tennent
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