Quality Assurance Risk Management

Brian J. Dougherty

Pottstown, PA ***** 484-***-****

**********@*****.*** https://www.linkedin.com/in/briandougherty007

Quality Assurance Professional

Innovative seasoned strategic leader with expertise in manufacturing and development environments, various stages of process auditing, supplier development including life science medical / biomedical combination products, electro-mechanical devices, packaging / labeling, raw materials; fiber, polymers, metals / plastic / composite materials, EDM and machining-processing, 3D processes, military, aerospace, automotive safety systems, food regulations and new technologies industries. Also versed in ISO 9001:2015, AS9100, ISO-19011-2018, 13485:2016, ISO 14001, TS16949, 16142:2017, and ISO14971 risk management requirements; please see certification listing.

Recognized for dedication, tenacity and providing direction while mentoring and developing talent. Strong practitioner of first-time quality; with focus on the customer. Planning and execution of continuous improvement initiatives throughout complex processes, sterilizations, systems, software and assemblies. EHS lead consistently delivering results, cost savings / avoidance in greater than goals. Coop/Intern coordinator, compliance / regulatory affairs – Quality Assurance liaison. Versed in Calibration IMTE – ISO-17025 & IVB - SME - computer systems / software validation, disaster planning and RoHS / REACH Directives. EU-MDR encouraging mutual respect through inclusion and teamwork.

Project Management Lean Six Sigma Methodologies Leadership Quality Engineering Compliance Global Change Agent Budgeting - Forecasting Supplier Relations Team Builder

Key Accomplishments

Subject matter expert (SME) in a wide array of GMP systems and associated procedural - regulatory requirements. Successfully developed key suppliers and customer liaison in six countries and approximately 23 states.

Quality assurance systems manager approver related to aligning product / process transfers and agreements.

Certified green belt, quality engineer, flawless project execution (FPX) and ISO-9001 lead auditor. Fluid in NIST, ASTM, ISO 9001:2015, AS9100, ISO-19011-2018, 13485:2016, ISO 14001, TS16949, 16142:2017, and ISO14971 risk management, codes of federal regulations (CFR), medical device single audit program (MDSAP). Design history reviews, design history file preparation according to the design requirements and planned phases including risk assessment, validations and verifications. UDI requirements, involved in Medical Device Reporting (MDR) regulation, master deliverable register / master document register coordinating deliverables between suppliers, batch records, CE marking, IEC60601-2104, regulations / specifications / marketing planning.

Validation and computer software validation- CSV support, pen testing, corrective action planning and gap analysis, combined with sales and marketing initiatives, post market activities - corporate and auditing accountability. Also enjoyed involvement in Centre of Excellence, support and as a contributor

Education

Master of Leadership Development (MLD), Pennsylvania State University, Great Valley, PA 3.7 GPA

Bachelor Art (BA), Organizational Dynamics, Immaculata University, Malvern, PA / College of Graduate Studies

Organization Leadership / Methods of Research / Adult Human Development / Leadership and

Health Ethics. 3.7 GPA

Associates Program, Electronic Technologies: C.H.I. Technical Institute & courses at Villanova University.

Professional Experience

INTERTEK, London England : hybrid 10-2022 - 05-2025

Registration audits primarily in the medical device industry worldwide. Please see Certifications and verifications.

SME Consultant -(ALKU-Olympic Medical) Client Manager 03-2022 - 10-2022

Specialized consulting services focused on deploying highly skilled consulting resources in the areas of Technologies, HCIT, Life Sciences, and Government Programs. Client Manager - 2022 : Certified in ISO-19011:2018 leading audit teams, MD-QMS ISO-13485:2016, ISO-13485:2016 Lead Auditor (TPECS), ISO9001:2015 Requirements (TPECS), and QM-9001:2015. Completed Plan - Do : Check - Act NBOG CV Guidance for QMS Auditors & Microbiology worldwide Assessors.

KMM GROUP, LTD- AKA (KVINC, M&S CENTERLESS GRINDING, MERON MEDICAL) Hatboro, PA 06-2019 - 03-2022

Quality Assurance Manager – www.linkedin.com/in/briandougherty007

Management Representative providing leadership, integrity to the highest ethical standards. Maintains, implements, and manages the AS9100, ISO 9001:2015, ISO 19011:2018 and ISO 13485:2016 certifications and ensures compliance with requirements of standards and customers while imposing same for supply base.

Merging the Quality Management System (QMS) of three entities including effective management reviews, complaint handling, Root Cause Analysis, NC - CAPA E2 system, change control, calibration maintenance, internal auditing, and manufacturing support. Environmental Health and Safety (EHS) trainer and ambassador.

Develops, manages, and improves Quality Assurance metrics using key performance indicators (KPI’s). Preparing and managing quality agreements with clients and vendors/suppliers, as well as various aspects of Validation (IQ, OQ, PQ) execution, risk assessment, development projects and preparation activities.

Leads company endeavors in proposing, planning, and implementing improvements in operations, quality principles and risk management.

ROYAL DSM, Exton, PA Biomedical Innovation Center - Netherlands 10/2018 - 05/2019

Medical Device / Biomedical - Quality Assurance Engineering/Subject Matter Expert/Consultant

Directed validation activities internally and at key suppliers, procedural updates, CAPA, engineering change notices, and complaint resolution of medical and biomedical products. Key customer contact leading continuous improvement team initiatives which resulted in successful resumption of combination product production. Steam in process: SIP, autoclave qualification, thermal mapping and temperature control. MDR supplier quality for technical file readiness, including material and product information, data integrity, and risk management activities for related suppliers.

DEPUY SYNTHES, a Johnson & Johnson Company, West Chester, PA 05/2000 – 06/2018

Franchise - Development and Supply Chain Manufacturer

Medical Device / Biomedical - Global Quality Assurance Specialist / Engineer / Manager

Provided improvements for global corporate systems and approvals resulting in GRQP/CIA and FDA observation closures and successes. Standardized medical device and bio upstream / downstream clean processing. Corrective and preventative actions (CAPA) internally & with suppliers (MDR), SOP's and related documentation.

Organized significant continuous improvement initiatives via green belt projects, scrap, and rework reductions averaging $200 - 672K per year and global standardization of operational procedures, enforcing the CFR, resulting in proven compliance integrity throughout the enterprise including the Synthecel pilot remote facility.

Orchestrated and refined validations (IQ-OQ/PQ), of state-of-the-art equipment and software - CSV, including Scanning Electron Microscopes (SEM) and custom apparatus in manufacturing, research locations and sterile packaging suppliers whereby decreasing variability in required results. Regulatory affairs interface for Class 3 Medical Devices.

Over 30 audits and internal / external suppliers (FDA / QHUB / TUV), resulting in no findings; and further verification to the success of continuous improvement initiatives through product quality surveillance.

Trainer in just-in-time / lean initiatives and good manufacturing practices (JIT / GMP) environment, including the 5Y's, Kaizen events, value stream mapping, and 5 S, and regulations ensuring FDA compliance.

Previous Related Experience

LEAR CORPORATION, New Castle, DE -Southfield, MI 1/1994 - 4/2000

Automotive - Quality Assurance Engineer / QA Manager

Responsible for quality assurance compliance with Saturn pilot plant. Accountable for all aspects of new product development, design transfer, and supplier activities in North America, Europe, Mexico, and the Czech Republic.

Lead Auditor (Entela / Continuous Improvement Dynamics Certified) for ISO/QS-9000-9001 quality system, training and successfully registration; and passing four years of subsequent audits. Performed quality improvement activities, design engineering changes, and production trial runs (PTR).

Guided QA personnel and team trainings on quality and automotive safety systems, advanced product approval process (APQP), control plans, and process flows, including production part approval process (PPAP).

Professional & Community Affiliations - Certifications, Patents & Publications

American Society for Quality (ASQ), International Society of Pharmaceutical-Medical Device Engineers (ISPE), Member Alpha Sigma Lambda Honor Society; Volunteer with Habitat for Humanity and Local Trauma Center.

Examiner- Pennsylvania Quality Leadership Foundation. Co-Patent holder for a medical product and intellectual property (IP) patent award and author of Medical Device publication; “Fragments”, and the Association for the

Advancement of Medical Instrumentation, (AAMI).

TL-Leading Management Systems Audit Teams (IS019011:2018) Certificate 3661399/222***-******,

AU-Management Systems Auditing (ISO19011:2018) Certificate 3661399/223***-******,

QM-Quality Management Systems (ISO9001:2015 Requirements) Certificate 3664235/223***-******,

ISO-9001:2015 Requirements (TPECS) Certificate 366****-******,

ISO13485:2016 Lead Auditor (TPECS) Certificate 366****-******,

MD-Medical Devices Quality Management Systems (ISO13485:2016) Certificate 3661399/222***-******.

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