MACLEAN DAN-JUMBO

Jacksonville, FL ***** adt6nw@r.postjobfree.com

203-***-**** linkedin.com/in/maclean-dan-jumbo-549b414

DESIGN/MANUFACTURING QUALITY ENGINEERING

Certified 6Sigma Black Belt

An analytical, results-driven quality management professional with extensive experience leading quality in Medical Devices, Biologics, Combination products, Pharmaceuticals and drug compounding. History of success in new product development, design for six sigma, validations (IQ, OQ and PQ), risk management, complaints / post market surveillance, CAPA, auditing, supplier management, cGMP / GLP, as well as strategic planning. Adept in FDA QSR, ISO, CMDR, and EU MDR regulations as applicable. Dedicated and accomplished professional with experience in off-shore contract manufacturers, MDSAP & ISO 13485. Committed to Six Sigma behavior. Core competencies include:

Design Control Risk Management (ISO-14971-2019) Supplier Quality

Root Cause Analysis Statistical Data Analysis Manufacturing Operations

Cross-Functional Leadership Process Validation (IQ, OQ, PQ) EU MDR Requirements

Internal & Supplier auditing Biological Risk Assessment FDA & Agencies Inspections

EXPERIENCE

Theragen Inc., Jacksonville, FL 2021-Present

Quality Systems Manager (Electromechanical Devices)

Manages the quality management systems of the multiple plants, including DME tech support for our product lines.

Responsible for complaints, Post Marker Surveillance, CAPA, Supplier management, Document control, auditing, inspection, and data analysis.

ZimmerBiomet Inc., Jacksonville, Florida 2019 - 2021

Design Quality Manager, (Orthopedic Medical Devices)

Oversees and manages activities of 6 Design Quality Engineers engaged in New Product Development, Risk Management, Supplier Quality Assurance, EU MDR updates, and Post Market Surveillance activities.

Manages projects within the Quality functions, including projects that involve cross-functional engagement from other departments, R & D, Regulatory, Sales and Marketing.

Support acquisitions and technology transfer of new products.

Subject Matter Expect (SME) in Design Control, Risk Management and Statistical Analysis.

MEDInstill Development Inc., New Milford, Connecticut 2015 - 2019

Director, Quality & Regulatory, (Devices and Pharmaceutical)

Oversaw, coached, directed and managed activities of team members engaged in New Product Development, Quality Assurance, Quality Control, Regulatory Compliance, Document Control and Records, internal audits, Supplier Quality Assurance, Failure Investigations, CAPA, Complaints, Post Market Surveillance and medical device reporting (MDR)

Contributed to the Quality Systems Compliance strategy - FDA, Certification Authorities and Foreign Regulators Inspections.

Managed off-shore, US critical Supplier and Contract Laboratories Management activities – Supplier evaluation, Surveillance, site cGMP and GLP audits, PPAP, Supplier agreements and audit reports.

Served as management representative (SME) for multiple Quality Systems elements: Medical Device, Pharmaceuticals and Nutrition. FDA/Regulators filings and responses.

ALLERGAN MEDICAL, Medford, Massachusetts 2014-2015

Manager, Design Quality Engineering

Provided overall direction to the following functions: Design Control, Risk Management, Customer complaints, Calibration, Post Market Surveillance, Quality Engineering, Quality planning and Supplier Quality.

MACLEAN DAN-JUMBO adt6nw@r.postjobfree.com PAGE TWO

Facilitated training and mentoring in areas of Design Controls and Risk Management strategies – User Needs, Design Input, Output, Verification, Validation, Transfer, Launch and Post market.

Directed quality planning activities, including FMEAs, risk analyses -HHE, Trace Matrix, DMR, DHR, and DHF.

Implemented electronic reporting for complaints, investigations, trending and metrics.

Provided qualification and validation strategy development and execution, including Design Verification & Validation, Test Methods Validation, and Process Validation-IQ-OQ-PQ, DOE, Regression and capability analysis.

PHILIPS HEALTHCARE, Wallingford, Connecticut 2012-2014

Senior QA / RA Engineer IV

Managed quality systems of local and off-shore contract manufacturers in China and Taiwan. Served as QA / RA representative on new product introduction and project teams.

Evaluated 510K and CE marking requirements for OEM design or process changes.

Appraised and documented risk assessments (ISO-14971), AFMEA, DFMEA, PFMEA and HHE.

Performed statistical analysis of process data; DOE, process mapping, IQ / OQ / PQ, control plans and summary reports via Minitab.

Managed plastics / components audit, complaints handling (Trackwise), CAPA, incoming of plastic molded components as well as final inspection reviews.

COVIDIEN, North Haven, Connecticut 2007-2012

Lead Senior Design Quality Engineer

Performed design control activities, including design validation/verification, design reviews, transfers, DHF management, component and product specifications, sample plan development, change control and nonconforming product analysis.

Managed stability / shelf-life Dept. with eight quality analysts and two quality engineers.

Supported PMA / 510K and Design Dossier / CE mark approval process.

Participated in clinical field test unit evaluation in operating room.

Evaluated and documented risk assessments (ISO-14971), DFMEA, PFMEA and HHE.

Contributed to preparation of IQ, OQ, and PQ protocols and write summary reports. Performed test method validations, including Gauge R&R studies via Minitab.

ADDITIONAL RELEVANT EXPERIENCE

COVIDIEN, Argyle, New York, Plant Quality Assurance Manager

TECHATLANTIC, INC., Berlin, Connecticut, Quality Assurance Manager

EDUCATION

SYRACUSE UNIVERSITY, Syracuse, New York

Bachelor of Science, B.Sc., Industrial Engineering and Operations Research

UNIVERSITY OF IBADAN, Ibadan

Master of Science, M.Sc., in Industrial/Manufacturing Engineering

CERTIFICATION

ASQ Certified Quality Engineer (CQE)

ASQ Certified Six Sigma Black Belt (CSSBB)

Tyco Healthcare Certified Design for Six Sigma

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