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Mark Proulx is listed as Quality & Regulatory Professional based in Fayetteville, North Carolina, United States. AeroLeads shows a work email signal at carltonnational.com and a matched LinkedIn profile for Mark Proulx.
Mark Proulx previously worked as Senior Quality Assurance Engineer at Pfizer and Senior Project Engineer at Boston Scientific. Mark Proulx holds Bs, Mass Communications from The University Of Southern Mississippi.
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Quality Management Systems | Project Management | Business Transformations | Gap Analysis & Assessment | Global Business Operations | Regulatory Compliance | Continuous Process Improvement Process Validations | Workflow Efficiencies | Strategic Planning | Biomedical Engineering | Contract Negotiation | Building Organizations | Turnaround Operations | cGMP | Consulting | Budget Management | Performance Improvement | Data Analytics | Business Intelligence | LEAN Six SigmaLet's be honest...you know you need to make changes to your culture, bring in people you can trust who have industry experience, and who can lead. You also need someone who can get to the heart of the matter quickly to drive improvements, eliminate waste, and establish that strong quality and business foundation you need. In short, you need strategic leadership with a Master's Degree in Getting S**t Done. The "same old, same old" doesn't work anymore. Paper-based systems aren't efficient or effective. Doing things because "we've always done it this way" is a philosophy that should be challenged. You need an innovator and risk-taker, but trust that this person is leading your company in a direction that matches your business goals and at the same time compliant to regulations. There's right, there's efficient, and there's probably what you're doing.When you want to improve your compliance, productivity, and effectiveness through innovative Quality systems, contact me. Streamlining operations by designing and implementing sustainable systems to improve handling of international issues, while standardizing communications processes to meet regulatory deadlines. Establishing infrastructure and building sustainable systems/operations as Director of Quality, for a new business in pharmaceuticals. Within one year this company was prepared to perform OTC fills, and had developed a marketing/sales plan that included estimated sales to be over $5M in the first year alone. Maximizing efficiencies, standardizing workflows, and increasing product throughput—saving one company $250K per year by moving component production locally, and setting the stage for an additional gain of $2M in revenues International experience working with China’s SFDA to install and qualify novel laser-based breast scanning technology and open up the China market for a new medical device company. Reducing close time by 300% for CAPAs, saving millions of dollars in unnecessary remediation costs. Email: md.proo@icloud.comWeb: http://markpru.com
Listed skills include Fda, Validation, Quality System, Capa, and 45 others.
A career timeline built from the work history available for this profile.
New York, New York, US
Operational on-floor support of quality engineering for Pharmaceutical, Biotech, Gene Therapy components and products for remediation, review, and approvals, including batch records, LIMS, MODA, MES, PLOGS, PDOCS, and AMPS systems and processes. Developing new event (deviation) processes by researching and enhancing risk processes, product impact, and.
Marlborough, MA, US
Bringing my expertise to assisting teams needing to implement EU MDR compliance to legacy products, developing regulatory documents for Technical File, perform Periodic Reviews of Tech Docs, and follow company documentation to perform MDD to MDR conversions.
Princeton, New Jersey, US
EU MDR expert leading the efforts to complete GSPRs for various client Class III implantable product lines.
Pearl River, New York, US
EU MDR expert redesigning processes and systems, assessing and redeveloping Risk Mgt Files for combination product (Class IIa device and drug), leading the technical team working with cross-functional resources to finalize Regulatory documentation, and subject matter expert on developing entire EU MDR Standard Technical File and Quality Management System.
Organizing, developing specific ISO 13485 and 21 CFR 820 Technical File methodology for a growth by acquisition medical device client. DHF and MDF documentation has to be acquired by various acquisition companies across the globe and a strategy is needed to deliver, organize, and archive needed documentation to show compliance to regulations. Leading the.
Auburn, Alabama, US
Sole expert resource generating company’s Design Control managing strategic recommendations and implementation plans for new combination product facility.
Chief architect of the facility’s Quality Management System by working with executive management developing and documenting processes, procedures, and responsibilities to meet FDA and State of Florida’s regulatory requirements generating a 503B Outsourcing facility.
Golden, Colorado, US
Hired to oversee strategy for closing legacy and newly opened CAPAs for a domestic division of an international infusion pump manufacturing company, utilizing Lean practices to streamline production processes, combine production records, reduce redundancies, and save processing time through a complete review of necessary processes, quality control.
Warsaw, Indiana, US
Single senior resource directly supporting the Department Head and junior PM overseeing strategy, resources, budget, and logistics of bringing hundreds of thousands of product SKUs into EU MDR compliance ahead of the May 2020 deadline by leading an international cross-functional team of R&D Engineering, Sales, Supplier Quality, Executive Management, and.
Inchinnan, Renfrewshire, Scotland, GB
R&D single resource consultant bringing a Sales-driven balloon catheter project out of mothballs, liaison to the Contract Manufacturing Organization located in Minneapolis, MN, and driving generating a completed STED Technical File from scratch in 10 months, as well as developing Quality and Manufacturing Agreements for client.
Gainesville, FL, US
Single resource project lead managing the transition of a paper-based medical device’s Quality Department to a fully realized and validated Pilgrim Quality Solutions’ SmartSolve system, Complaints Module.
Bad Homburg, Frankfurt, DE
Single resource team lead tasked with managing and closing 14 Distribution Centers’ Corrective and Preventative Action Plans (CPAPs), closing 60% of open CAPAs within 30 days through an exercise of QMS documentation review and experience in closing risk stratified and redefined CAPAs.
San Diego, CA, US
Quality Engineer leading a team of three junior consultants to inventory, assess, and validate anodizing and metal fabrication processes to support process transfers to new plant.
Lexington, MA, US
Single resource lead auditor performing a comprehensive investigation into all company processes. When complete, company requested consultant services to remediate a broad base of process improvements, as well as compliance and policy corrections.
Marlborough, MA, US
Single resource quality engineer developing a Device History File for a legacy IVDD that had been on the market for over 18 years, per FDA Form-483 observations. Performed comprehensive investigation and research into fully paper-based historical files to create a successful electronic DHF in 8 months.
Managed a downstream of 13 quality individuals and managers, supporting all biologic fractionating manufacturing processes and product. Introduced novel quality training sessions to draw in cross functional personnel across all departments, lead a process of improving batch record approvals through a program of mentoring junior support personnel, and.
Amsterdam, Noord-Holland, NL
End-to-end single resource PM of international Corrections & Removals department for a major multimillion dollar diagnostic medical device manufacturer while under a division-wide Consent Decree. Developed a system by which Risk Management (HHA) could be scientifically calculated and probabilities established to better document risk in language the FDA.
Single resource quality engineer working with Supply Quality department head to develop and generate a complete and comprehensive QMS including Supplier Qualifications, Supplier Scorecards, Quality Agreements, Manufacturing Agreements, generating all SOPs, Receiving Inspection statistical rationale, Test Method Validation, developing and issuing SCARS, and.
Raynham, MA, US
DePuy/Synthes | Senior QA Engineer August 2013 | March 2014Team Lead of consultants to investigate areas of QMS compliance throughout a major Johnson and Johnson acquisition of orthopedic medical device fabrication facilities (Elmira, NY and West Palm Beach, FL), assessing equipment qualifications, documentation accuracy, and overall cGMP compliance in.
Minneapolis, MN, US
Compliance quality engineer team member assigned to perform data analytics on existing open CAPAs throughout the international organization. This effort was spearheaded to define open CAPA issues, reasons for timeline delays, strategize logistics, and create definitive teams and plans for closing CAPAs across the board working with Department Heads.
Department Head overseeing operations: throughput, quality compliance, equipment qualifications, quality records, batch records, developing KPIs, training all levels of personnel including executive management on Code of Federal Regulations. Developed and established company’s first ever Quality Management System. Owner sold company to start Ocean.
Boca Raton, Florida, US
Department Head advising executive management on regulations for manufacturing and distributing Homeopathic drugs, while establishing a total QMS aligned with FDA regulations and CMC operations. Designed processes, procedures, and documentation control systems in compliance with regulatory and quality standards. As a direct result of the research, the.
Wayne, PA, US
Team Lead of four engineers, tasked with a complete and comprehensive investigation into all equipment and processes in corporate’s Tecate, MX facility. Because of a well-organized effort, team managed to completely qualify the entire facility in six months, well ahead of schedule set by corporate as a target.
Team Lead Engineer leading DHF investigations, CAPA investigations, process validation protocols and execution, equipment qualification protocols, IQ, OQ, PQ development, statistical sampling development, and generating Final Reports to qualify efforts to transfer major processes from Santa Anna, TX and Puerto Rico to Juarez, MX.
Marlborough, MA, US
Single resource part of a major effort by a multimillion-dollar division in Doral, FL (Project Horizon) to assess all Technical File documentation on every acquisition product line purchased by corporate, develop gap assessments, and perform all process and product validations over the course of 5 months.
Deerfield Beach, FL, US
Department Head, hired to support executive management with the development of a total QMS, supporting the growth of a $200K/year profit business to over $2 million a year by implementing Lean philosophy, driving an increase of production throughput over 300%, implementing processes that lowered process times by over 200%, and moving cassette injection.
Fort Lauderdale, Florida, US
International installation and service manager for medical device company that had developed a one-of-its-kind laser-based breast scanning device that imaged blood flow within a person's breast to determine the difference between normal blood flow and angiogenesis (the distinctive marker of growing great cancers). Installed and de-installed 22 units all.
Quick answers generated from the profile data available on this page.
Mark Proulx is listed as Quality & Regulatory Professional.
AeroLeads has found 1 work email signal at @carltonnational.com for Mark Proulx.
Mark Proulx is based in Fayetteville, North Carolina, United States.
Mark Proulx has worked for Pfizer, Boston Scientific, Integra Lifesciences, Acorda Therapeutics, Inc., and Coopersurgical.
You can use AeroLeads to view verified contact signals for Mark Proulx, including work email, phone, and LinkedIn data when available.
Mark Proulx holds Bs, Mass Communications from The University Of Southern Mississippi.
Mark Proulx is listed with skills including Fda, Validation, Quality System, Capa, Medical Devices, Gmp, Quality Assurance, and Six Sigma.
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