Quality Engineer Manager

CARLOS ARRISCORRETA Ph.D., CQE, CLA

801-***-****· ******.************@*****.*** Highland, Utah 84003 SUMMARY

Experienced Quality leader with over 15 years of experience communicating with FDA and international regulatory agencies across industries, including Medical Device Manufacturing, Contract Manufacturing and Diagnostics. Proficient in Quality Systems Management, with a distinguished understanding of regulation adherence and meticulous inspections. Committed to quality service and mentoring teams creating high standards of providing quality improvement. AREAS OF EXCELLENCE

• Multi-site Team Leadership

• Audit Readiness & Compliance

• Cross Functional Leadership

• Risk and Supplier Management

• Project Management

• CAPA & Field Corrective Action

• Remediation & Consent Decree

• Post Market Surveillance

• Six Sigma / Continuous Improvement

• Spanish & Portuguese

REGULATION EXPERTISE

21 CFR: 803, 806, 820; ISO: 9001, 134**-*****; cGMP; MDSAP, European Medical Device Regulation (EU MDR 2017/745); Canadian SOR/98-282; Japanese MHLW 169; ANVISA RDC 751/2022 (Brazil); NOM-241-SSA1-2012 (Mexico). IVD/IVDR. COMPUTER SKILLS

• Quality Software: TrackWise, Master Control, Minitab, MathCAD, MATLAB, C++

• Microsoft: Word, Excel, Power Point, Access, Visio, Project EXPERIENCE

Vice President of Quality Assurance and Regulatory Affairs Precision One Medical San Diego, CA Mar 2024 to Jan 2025 Manufacturer of dental implants

• Led Quality Assurance & Regulatory Affairs, ensuring QMS compliance and holding executive responsibility for regulatory functions.

• Successfully guided the company through an ISO surveillance audit with zero findings.

• Transitioned the QMS to an electronic system (1factory & Propel), increasing efficiency by at least 25%.

• Identified and mitigated compliance risks, ensuring 100% completion of internal audits in 2023.

• Restructured quality and regulatory teams, improving collaboration and morale.

• Implemented strategic quality and regulatory processes, aligning with business objectives and compliance standards.

• Provided expert counsel on NCMRs, CAPAs, complaints, and change controls, driving regulatory improvements.

• Established and maintained the internal audit program, ensuring compliance with 21 CFR 820 and ISO 13485:2016. Quality, Regulatory and Compliance Consulting

Principal Consultant Highland, UT June 2019- Present Independently owned business securing contracts with large and small businesses to supply Quality Assurance Services.

• Led audit readiness, CAPAs, field actions, and post-market surveillance across three businesses annually.

• Developed QMS for startups, building teams that improved audit readiness and streamlined compliance processes by 50%.

• Conducted domestic audits per ISO 13485, MDSAP, and 21 CFR 820, ensuring compliance.

• Implemented TrackWise QMS, optimizing complaint investigations and improving completion time by 20%.

• Directed global Management Review, delivering timely and accurate reports for Executive Management.

• Established a CAPA program, managing up to 36 CAPAs simultaneously to ensure regulatory compliance.

• Oversaw up to 15 cross-functional projects, driving process improvements across multiple business units.

• Developed QMS for startups, building teams to execute complaints, CAPAs, NCs, and internal audits.

• Authored a statistical-based MDR procedure, improving reporting efficiency by approximately 50%.

• Performed analyses using Lean Manufacturing and Six Sigma approaches, including DMAIC, Root Cause Corrective Action

(RCCA), 5S, and other quality tools to drive efficiency and cost savings. Director of Quality

Biomerics & Biosonix Salt Lake City, UT Nov 2022 – Aug 2023 Medical device contract manufacturer, delivering on the complex demands of bringing interventional components and devices to life. Products included: endoscopes, balloon catheters, advanced catheters, complex extrusions, and imaged guided intervention.

• Led audit readiness, CAPAs, field actions, and post-market surveillance across three businesses annually, ensuring 100% compliance.

• Conducted domestic and international audits per ISO 13485, MDSAP, and 21 CFR 820, achieving a 90% compliance rate.

• Directed global Management Review, ensuring 100% on-time completion of executive reports and presentations.

• Established a CAPA program, effectively managing up to 36 CAPAs simultaneously, reducing compliance gaps by 40%.

• Oversaw over 15 cross-functional projects, increasing process efficiency across multiple business units.

• Authored a statistical-based MDR procedure, improving reporting efficiency, reducing compliance risks significantly.

• Ensured and improved GMPs and GDPs by implementing a “Train-the-Trainer” system and certifying quality manager engineers, manufacturing leads and operators. Achieved an approximate 95% improvement in GDP awareness and compliance. Corporate Director of Regulatory Compliance

Getinge Wayne, NJ Feb 2017-May 2019

Global medical technology company's product portfolio encompasses a range of products for life sciences and hospitals, including endoscopes, catheters, Intra-aortic balloon pumps, Endoscopic Vein Harvesting, Beating Heart Surgery, and more.

• Led compliance, audit readiness, and global complaint management across 4 divisions, overseeing FCAs, adverse event reporting, vigilance, and post-market KPIs, CAPAs, improving operational efficiency by at least 80%.

• Represented the company in over 20 FDA and international audits annually, developing 483 responses, Warning Letter actions, and CAPAs, resulting in zero non-compliance findings to the CAPA responses.

• Spearheaded the USA in a global project to harmonize TrackWise QMS for Complaints, successfully completing the initiative on schedule, enhancing complaint handling efficiency.

• Managed over 30 FDA CAPAs annually, leading cross-functional teams to mitigate compliance risks and ensure timely resolution, improving CAPA closure times by a minimum of 25%.

• Eliminated backlogs in complaint investigations, MDRs, CAPAs, HHEs, and FCAs, improving regulatory compliance and reducing investigation time.

• Collaborated with Operations leadership cross functionally to implement corrective actions for systemic risks, driving timely remediation and achieving a minimum of 80% compliance with audit requirements.

• Reviewed and approved 10 global medical reports monthly, ensuring MDR, ISO, and vigilance compliance, improving report accuracy.

• Directed cross-functional remediation projects, assessing SOPs for CFR & ISO compliance, achieving at least 80% SOP adherence across all divisions.

• Conducted domestic and international (Antalya,Turkey) audits per ISO 13485, MDSAP, and 21 CFR 820, ensuring compliance.

• Managed a team of 6 direct reports and over 40 staff, including Senior Managers, Medical Doctors, Engineers, Analysts, and Technicians, with 50% of direct reports promoted.

Senior Manager of Quality Assurance & Field Assurance CR BARD (BECTON DICKINSON) Salt Lake City, UT Oct 2008-Jan 2017 Developer, manufacturer, and marketer of medical technologies in the fields of vascular, urology, oncology, and surgical; including catheters, ports, needles, endoscope systems, and vision systems.

• Led Field Action (FCA) processes and Board meetings, ensuring 100% regulatory compliance and managing FDA communications across 12 annual meetings.

• Oversaw Quality Systems, driving efficiency in CAPAs, Complaint Handling, MDR/eMDR, Post-Market Surveillance, and Vigilance.

• Streamlined CAPA and Complaint Handling by transitioning to TrackWise (eQMS), enhancing compliance, traceability, and process efficiency.

• Resolved critical quality issues (sterility breaches, mislabeling, catheter leakage) using DMAIC statistical techniques, leading to a 10% complaint reduction and 5% MDR decrease.

• Directed global regulatory projects across LATAM, Mexico, Brazil, Puerto Rico, Japan, China, and Taiwan, managing 8–10 projects simultaneously.

• Led the cross-functional Quality Council (QC, PMS, R&D, three manufacturing plants from Mexico and one in Puerto Rico), coordinating multi-plant efforts to achieve complaint reduction and MDR improvement.

• Developed and presented Management Review reports, ensuring timely executive decision-making and quality strategy alignment.

• Mentored and promoted talent, with 50% of direct reports advancing under leadership. EDUCATION AND TRAINING

University of Utah

Ph.D. in Mechanical Engineering Dissertation

“Statistical Modeling for the Corrosion Fatigue of Aluminum Alloys 7075-T6 and 2024-T3” Brigham Young University

Bachelor of Science in Chemical Engineering

Cornell University

Executive Leadership Development Program Certification QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 Oriel STAT A MATRIX

Certified Lead Auditor Certification, BSI,

Certificate Number No. 964****-******

Certified Quality Engineer Certification (CQE),

American Society of Quality, Certification Number 48207

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