Yasmin Amengual Diaz
Lakewood Ranch
Summary
Quality assurance professional with comprehensive experience in equipment, process and system validations regulated manufacturing environments. Proven expertise in developing, executing and approving validation deliverables including IQ, OQ, PQ, TMVs. Strong knowledge of ISO 13485, 21 CFR 820 QMSR, EU MDR, and MDSAP with hands on experience in nonconformances, CAPA and quality systems compliance. for a collaborative approach and delivering consistent, reliable results through adaptable strategies. Exhibits strong analytical and problem-solving skills along with effective communication.
Overview
28
28
years of professional experience
3
3
Certifications
Work History
Senior Quality Assurance Manager
Mermaid Medical AS
Sarasota
05.2021 - 01.2026
- Appointed as Management Representative to maintain and update Quality Management System (QMS).
- Led Document Control, Quality Inspections, Nonconformance Processes, and Supplier Management initiatives.
- Managed internal and external audits, ensuring compliance with regulatory standards.
- Oversaw budgeting, resource allocation, and risk management for QA-related projects.
- Established strong QA team through recruitment, training, and mentoring of professionals.
- Analyzed quality assurance metrics and conducted root cause analyses to reduce defect rates.
- Collaborated with cross-functional teams to implement process improvements and resolve quality issues.
- Provided progress reports to stakeholders, highlighting achievements, risks, and mitigation plans.
Engineering Quality
Exactech
Sarasota
04.2020 - 05.2021
- Ensured manufacturing and production processes complied with internal and external regulatory standards.
- Developed quality inspection plans, defined product/process requirements, and implemented verification & validation protocols (IQ, OQ, PQ).
- Led MRB meetings, CAPA projects, and product complaint investigations to drive process improvements.
- Provided quality engineering support for product and process changes, including supplier quality management.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Worked effectively in fast-paced environments.
- Self-motivated, with a strong sense of personal responsibility.
- Skilled at working independently and collaboratively in a team environment.
- Demonstrated strong organizational and time management skills while managing multiple projects.
- Managed time efficiently to complete all tasks within deadlines.
Quality Systems Manager
Apyx Medical Corporation
Clearwater
11.2018 - 09.2019
- Appointed as Management Representative responsible for maintaining and updating the Quality Management System (QMS).
- Achieved ISO 13485, MDSAP and MDD certification through diligent preparation, documentation, and adherence to international standards of quality management.
- Assured regulatory compliance with applicable industry standards by staying abreast of updates or changes in requirements, adjusting organizational policies accordingly when necessary.
- Led MRB meetings, CAPA projects, and product complaint investigations to drive process improvements.
- Advised management of quality audit non-compliance issues to facilitate improved audit compliance rates.
- Developed quality inspection plans, defined product/process inspection requirements, and implemented verification & validation protocols (IQ, OQ, PQ).
- Provided quality engineering support for product and process changes, including supplier quality management.
- Conducted thorough risk assessments to identify potential issues and develop appropriate mitigation strategies.
- Implemented comprehensive training programs for staff, ensuring consistent understanding and application of established processes across all departments.
- Mentored fellow team members on best practices in quality assurance, fostering a culture of continuous learning and growth.
- Ensured manufacturing and production processes complied with internal and external regulatory standards.
- Scheduled and managed internal and supplier-based audits to verify compliance with document control procedures.
- Evaluated quality problems and performed assessments to identify and resolve issues.
- Participated in targeted customer audit initiatives and produced required documentation to support verifiable results.
- Improved quality processes for increased efficiency and effectiveness.
- Collaborated with Research and Development on new product launches, guaranteeing a seamless introduction into the market without compromising on quality standards.
- Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production.
Quality Engineer
Dentsply Sirona
Sarasota
10.2014 - 11.2018
- Worked with Operations, Process Engineers, and R&D to develop quality specifications ensuring FDA & ISO compliance.
- Led process validation, change control, and risk assessment activities for new product development and technology transfers.
- Managed CAPA system, Supplier Quality Program, and Material Review Board (MRB) processes.
- Develop and execute validations (IQ, OQ, PQ) new processes applying statistical analysis and samplings.
- Review of and approval of the calibration records.
- Developed inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
- Performed quality inspections and issued non-conformance report detailing the non-conforming material issues.
- Contributed to root cause analysis to determine core reason for failures and errors.
- Conducted detailed audits to ensure adherence to ISO 13485, MDSAP & MDD standards, maintaining a high level of compliance throughout the organization.
- Participate in various process improvements initiatives to eliminate waste and enhance efficiency.
Manufacturing Supervisor / EH&S Manager
Dentsply Sirona
PR
02.1998 - 10.2014
- Managed manufacturing operations, optimizing production efficiency while reducing costs.
- Conducted SOP & GMP training and led regulatory audits.
- Maintained open lines of communication between management and staff, fostering trust and transparency throughout the organization.
- Developed and implemented Corporate Environmental Health & Safety programs.
- Conduct EH&S Corporate audits across the organization.
- Appointed as Safety Officer.
- Responsible for external inspections and audits (OSHA, EPA, DOT).
- Led safety meetings and monitored compliance with gear requirements and best practices.
- Led Kaizen events for process improvements and Lean Manufacturing initiatives.
- Performed accident investigations.
- Worked cross-functionally for new product developments with another sister divisions.
- Conducted root cause analysis on production issues, identifying solutions that prevented future recurrence of similar problems.
- Monitored production schedules to ensure on-time delivery of products, meeting customer expectations consistently.
- Managed departmental performance measures.
- Ordered parts and materials for the Manufacturing Departments as needed.
Education
Bachelor's Degree - Microbiology
University of Puerto Rico
Humacao Branch05-1997
Skills
- Quality management systems (ISO 13485, 21 CFR 820, MDSAP, MDR)
- Effective communication and interpersonal skills
- Attention to detail
- Corrective and preventive action (CAPA)
- Root cause analysis (RCA)
- Regulatory compliance and audits (ISO 13485, MDSAP, FDA, MDR)
- Risk management
- Failure mode and effects analysis (FMEA)
- Organizational and time management skills
- Team collaboration and independence
- Adaptability to technology
- Budget management
- Financial documentation handling
- Supplier quality assurance
- Vendor management
- Continuous improvement mindset
- Team mentorship
- Cross-functional leadership
- Critical thinking and analysis
- Strategic planning for goals
- Talent acquisition strategies
- Regulatory compliance expertise
- Complaint investigation processes
- Strong work ethic
Certification
ISO 13485:2016 Auditor
Languages
English, Full Professional
Spanish, Native/Bilingual
Timeline
Senior Quality Assurance Manager
Mermaid Medical AS
05.2021 - 01.2026
Engineering Quality
Exactech
04.2020 - 05.2021
Quality Systems Manager
Apyx Medical Corporation
11.2018 - 09.2019
Quality Engineer
Dentsply Sirona
10.2014 - 11.2018
Manufacturing Supervisor / EH&S Manager
Dentsply Sirona
02.1998 - 10.2014
Bachelor's Degree - Microbiology
University of Puerto Rico