Dedicated QA professional with extensive experience in medical device, aerospace, & high tech commercial products. 5 ASQ certifications & RAPS RAC (retired). 15 years QA management experience (director/manager). I am a believer in fact based decision making & metrics driven continuous improvement. My career has provided experience in all phases of quality management systems (QMS), within IS0 13485, ISO 9001, & the FDA QSR. Have been the responsible QMS "Management Rep." in multiple orgs. In recent roles I led QMS integrations related to acquisition, by transitioning legacy QMS's to meet new requirements. Have championed transitions at GE Healthcare locations in Burlington, VT, & Wilmington, MA. My efforts have been directly associated with FDA Inspection results at 3 organizations with a result of no 483 report being issued. During roles at Conmed & Welch Allyn, was part of teams that implemented significant updates related to regulatory inputs. At Anoplate & NetTest, I personally led transition of ISO 9001 certified QMS's to meet new requirements associated with quality standard updates. Also at Anoplate, I led implementation of aerospace NADCAP AC 7108 chemical processing certification. These various roles have provided a path that demonstrate my accomplishments in leadership, contribution, results, and achievement as a quality systems champion. Along the way my activities have included QA guidance in ISO compliant new product development, FDA design controls, compliance approvals in safety & emc, consideration & management of international CE requirements, submittal of 510(K) for FDA class II device clearance, international licensing for medical devices, supplier management & relationships, member of a corporate QMS compliance audit team, internal audit management, internal & supplier auditor, CAPA Leadership, risk management, and strategic quality planning.

Director of Quality and Regulatory Affairs @ Management Representative for the quality management system and regulatory stewardship for an innovative provider of process development, packaging solutions, and custom manufacturing for diverse medical device customers. From June 2014 to Present (1 year 7 months) Greater Boston AreaIndependent Consultant @ Independent Consultant for the medical device industry specializing in quality management systems and regulatory activities. Provides gap analysis service for QMS compliance to FDA QSR and ISO 13485. Revise and creates Standard Operating procedures as needed. Conducts internal audits or coaches and enables creation of internal audit systems. Provides training on the CAPA process and use of structured root cause analysis tools as well as taking ownership and driving on existing/open CAPAs. Can establish a supplier controls process and conduct Supplier audits. Also consults on Risk Management for medical devices (14971:2012), process validation, FDA Inspection preparedness, complaint handling, and more. From March 2014 to May 2014 (3 months) Greater Boston AreaDirector Quality Management, Regulatory Compliance @ Responsible for origination, management and compliance of the quality management system and overall support of quality audits, regulator inspections, and regulatory affairs at a 25 person start-up company. From May 2013 to February 2014 (10 months) Sr. Site Leader, QA, SMR, Wilmington, MA @ Management Representative, responsible for Quality Management System, FDA readiness, ISO 13485 Quality System, and overall quality aspects for an FDA registered manufacturer of a Class II specialty MR system. From March 2011 to May 2013 (2 years 3 months) Sr. Site Leader, QA/RA @ Management Rep. with overall Site responsibility for GE Quality Management System. Site has 2 seperate P&Ls and is involved in design and distribution of medical industry software applications. From October 2008 to March 2011 (2 years 6 months) Plant Manager, Quality Assurance @ Overall Quality Assurance responsibility for a Central NY manufacturing facility, Class I and Class II devices, 1 drug product, ISO13485 Certified, FDA registered site. From 2008 to 2008 (less than a year) Manager, Quality Systems @ Responsible for overal quality systems management with strategic focus on 3rd party audit facilitation, CAPA, Document Control, Receiving Inspection, MRB and various remediation activities. Part of a small quality management team that accerated quality culture and change management in a short period and culminating in a very successful FDA inspection with no 483. From June 2006 to December 2007 (1 year 7 months) Sr. Regulatory Engineer @ Responsible for RA activities: product licensing, 510(k) product submissions to FDA, CE technical file administration using the STED format, special projects and auditing associated regulatory input remediation, management of Agency compliance testing for medical device related Safety and EMC testing. From June 2004 to June 2006 (2 years 1 month) Director of Quality @ Management Rep for ISO 9001 certified quality management system. Full responsibility for the quality system and QA Dept.. Led transition from ISO 9001:1994 to ISO 9001: 2000. Led implementation of NADCAP AC 7108 Chemical Processing system certification. From January 2003 to July 2004 (1 year 7 months) Director of Quality @ Responsible for quality management system and as QMS Management Representative. Key areas were product inspection, calibration system, internal auditing, audit facilitator for customer audits, QA representation for design projects, analysis of warranty data and associated product improvement. Created SOP updates - process approach pathway to transition from ISO 9001:1994 to ISO 9001:2000. Consulted for other NetTest organizations in Beaverton, Or and Toronto, Canada. From December 2000 to January 2003 (2 years 2 months)

BS, Quality Assurance- Quality Control @ Kennedy Western University From 1993 to 1994 AS, Business Administration @ State University of New York, Morrisville From 1990 to 1992 AAS, Electrical Technology @ Niagara County Community College Mark Simmons is skilled in: Quality Management, Quality Systems, Quality Auditing, ISO 13485, CAPA, Medical Devices, QSR, Design Control, FDA, Quality Assurance, Quality Engineering, CQA, ISO 14971, Validation, Quality System