Family
Heidy Joaquin
Quality Assurance Professional
Santo Domingo,01
Summary
Professional with over 20 years of experience in Quality Assurance and Process Engineering. Experience in Project Quality Engineering, Process Qualification and Quality Systems (Customer Complaints, Corrective & Preventive Actions), Internal and External Audit and Manufacturing in Medical Devices Industry
Overview
17
17
years of professional experience
4
4
years of post-secondary education
6
6
Certifications
2
2
Languages
Work History
Corporate Quality Director, Case for Quality Program Manager
Edwards Lifesciences
05.2022 - Current
- Work closely with organizational leadership and board of directors to guide operational strategy.
- Enhance team collaboration through regular communication, goal setting, and performance evaluations.
- Form strategic partnerships and connected with internal and externals key medical device industry organizations (e.g., FDA, MDIC, ISACA)
- Cultivate positive work environment that fostered employee engagement into Case for Quality Program
- Skills: Case for Quality ▪ CMMI Practitioner ▪ Continuous Improvement ▪ Annual Operating Planning ▪ Internal Auditor ▪ CAPA ▪ Root Cause Analysis ▪ Lead Auditor ▪ Quality Assurance ▪ ISO13485 ▪ Regulation 21CFR820 ▪ MDSAP ▪ Medical Devices ▪ Risk Management ▪ Process Standardization ▪ Decision Making ▪ Process Redesign ▪ Design Transfer / Products ▪ Change Management ▪ Coaching ▪ Lean Six Sigma ▪ FMEA ▪ QCP ▪ DMAIC ▪ Complaint Handling ▪ MDD/MDR ▪ Program Management ▪
Quality Manger, Compliance
Edwards Lifesciences
04.2019 - 05.2022
- Maximized performance by monitoring daily activities and mentoring team members.
- Communicated clearly with employees, suppliers and stakeholders to keep everyone on same page and working toward established business goals.
- Monitored and analyzed business performance to identify areas of improvement and make necessary adjustments.
- Achieved departmental goals by developing and executing strategic plans and performance metrics.
- Skills: Talent Development ▪ Supervision ▪ Internal Auditor ▪ CAPA ▪ Root Cause Analysis ▪ Lead Auditor ▪ Process Validation Trainer ▪ Quality Assurance ▪ ISO13485 ▪ Regulation 21CFR820 ▪ MDSAP ▪ Medical Devices ▪ Risk Management ▪ Supplier Validation ▪ Decision Making ▪ Process Redesign ▪ Design Transfer / Products ▪ Change Management ▪ Coaching ▪ Lean Six Sigma ▪ FMEA ▪ QCP ▪ DMAIC ▪ Complaint Handling▪ MDD/MDR ▪
Associate Manager, Project Quality
Edwards Lifesciences
04.2017 - 04.2019
- Managed cross-functional projects, ensuring timely completion and alignment with company objectives.
- Led team meetings regularly to discuss progress updates, identify challenges or roadblocks, and provide guidance towards successful project completion.
- Enhanced team productivity by implementing efficient project management strategies.
- Skills: Project Management ▪ Talent Development ▪ Supervision ▪ Process Validation Expertise ▪ IQ ▪ OQ ▪ PQ ▪ TMV ▪ CAPA ▪ Root Cause Analysis ▪ Internal Auditor ▪ Process Validation Trainer ▪ Quality Assurance ▪ ISO13485 ▪ Regulation 21CFR820 ▪ MDSAP ▪ Medical Devices ▪ Risk Management ▪ Supplier Validation ▪ Decision Making ▪ Process Redesign ▪ Design Transfer / Products▪ Change Management ▪ Coaching ▪ Lean Six Sigma ▪ FMEA ▪ QCP ▪ DMAIC ▪
Staff, Project Quality
Edwards Lifesciences
07.2016 - 04.2017
- Responsible of maintain the metrics for the Quality Systems of CAPA & Customer Complaints.
- Follow up on time execution of each phase of CAPA and Complaints, assisting owners and providing guidance to assure appropriate record completion.
- Excellent communication skills, both verbal and written.
- Self-motivated, with strong sense of personal responsibility.
- Skills: Design Transfer / Products ▪ Change Management ▪ Project Management ▪ Process Validation Expertise ▪ IQ ▪ OQ ▪ PQ ▪ TMV ▪ Supplier Validation ▪ CAPA ▪ Root Cause Analysis ▪ Internal Audit ▪ External Audit ▪ Process Validation Trainer ▪ Quality Assurance ▪ ISO13485 ▪ Regulation 21CFR820 ▪ MDSAP ▪ Medical Devices ▪ Risk Management ▪ Decision Making ▪ Process Redesign ▪ Lean Six Sigma ▪ FMEA ▪ QCP ▪ DMAIC ▪ Talent Development ▪ Supervision ▪ Validation Approval ▪
Staff Quality/ Customer Complaints Lead
Edwards Lifesciences
10.2013 - 06.2016
- Plan and distribute assignments to customer complaint staff.
- Promote use of investigation techniques (e.g., DMAIC, Ishikawa) to identify root cause, corrective, preventive and containment actions.
- Monitor key indicators of Customer Complaint System. Improved customer complaint system obtaining reduction on top 5 complaint issues between 18% and 85%.
- Excellent communication skills, both verbal and written
- Worked well in team setting, providing support and guidance.
- Skills: Customer Complaints Handling ▪ Root Cause Analysis ▪ Problem Solving ▪ Product Evaluation ▪ Performance Indicators Management ▪ Non-Conformance Handling ▪ Coaching ▪ Resource Management ▪ Talent Development ▪ Action Plan Follow Up ▪ Inter-plant Communication ▪ Correctives & Preventive Actions ▪ Internal Audit ▪ External Audit ▪ Risk Management ▪ Product Impact Evaluation ▪
Staff Engineer, Process Engineering
Edwards Lifesciences
05.2012 - 09.2013
- Mentored junior engineers by providing guidance on best practices and industry standards, fostering professional growth.
- Managed multiple concurrent projects, ensuring timely completion and adherence to budget constraints.
- Collaborated with cross-functional teams to develop integrated systems, optimizing overall performance.
- Presented technical findings and recommendations to key stakeholders with clarity, supporting informed decision-making processes
- Skills: Project Management ▪ Budget Management ▪ TMV ▪Talent Development ▪ Supervision ▪ IQ ▪ OQ ▪ PQ ▪ TMV ▪ CAPA ▪ Root Cause Analysis ▪ Performance Indicator Analysis ▪ Quality Assurance ▪ ISO13485 ▪ Regulation 21CFR820 ▪ Medical Devices ▪ Risk Management ▪ Decision Making ▪ Process Redesign ▪ Lean Six Sigma ▪ DMAIC ▪ Resource Management ▪
Senior Engineer, Customer Complaints & CAPA
Covidien
01.2007 - 04.2012
- Monitored and coach employee performance to keep projects on task.
- Mentored junior engineers, providing guidance in best practices and fostering professional growth opportunities
- Promoted teamwork and demonstrated effective communication skills to improve collaboration among personnel.
- Defined engineering problems, collected data, established facts and execute investigations leading to root cause to solve product and process issues.
- Managed over 100 customer complaint investigation and over 50 CAPAs with 100% effectiveness on implemented corrective actions.
- Skills: Customer Complaints Handling ▪ Root Cause Analysis ▪ Effectiveness Verification ▪ Problem Solving ▪ Scrap / Defect Reduction ▪ Process Optimization ▪ Product Impact Evaluation ▪ Non-Conformance Management ▪Corrective & Preventive Actions ▪ Raw Material Validation ▪ Continuous Improvement ▪
Education
Industrial Engineer -
Instituto Tecnológico De Santo Domingo INTEC
Santo Domingo, 01 01.1998 - 05.2002
Lead Auditor -
AQS
Puerto RicoPractitioner -
ISACA
RemoteMDSAP Certification -
Oriel Stat A Matrix
Irvine, California Skills
Partnerships and Alliances
Risk Management
Verbal and written communication
Contract Negotiation
Program Management
Strategic Planning
Issues Resolution
Regulatory Compliance
Contract and Vendor Management
Corporate Communications
People and team Management
Budget Control
Certification
Six Sigma Green Belt - Tyco Healthcare
References
- Arquimedes Dominguez, B.Braun, (809) 901-9400, arquimedes.dominguez@gmail.com
- Diana Monsalve, Ecolab, (829) 945-4477, diana.e.monsalve@gmail.com
- Laura Quiterio, AccuMed, (809) 858-4893, laquiterio@yahoo.com
Interests
Volleyball
Sign, Karaoke
Travel
Timeline
Corporate Quality Director, Case for Quality Program Manager
Edwards Lifesciences
05.2022 - Current
Quality Manger, Compliance
Edwards Lifesciences
04.2019 - 05.2022
Associate Manager, Project Quality
Edwards Lifesciences
04.2017 - 04.2019
Staff, Project Quality
Edwards Lifesciences
07.2016 - 04.2017
Staff Quality/ Customer Complaints Lead
Edwards Lifesciences
10.2013 - 06.2016
Staff Engineer, Process Engineering
Edwards Lifesciences
05.2012 - 09.2013
Senior Engineer, Customer Complaints & CAPA
Covidien
01.2007 - 04.2012
Industrial Engineer -
Instituto Tecnológico De Santo Domingo INTEC
01.1998 - 05.2002
Lead Auditor -
AQS
Practitioner -
ISACA
MDSAP Certification -
Oriel Stat A Matrix