Steve Mounts Email and Phone Number
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An innovative problem solver who is passionate about common sense solutions to overcome the challenges presented by operating in the tightly regulated medical device industry. Seasoned leadership skills with a history of successfully building and managing high performing, interdisciplinary teams. Proven track record of implementing programs that improve product yields, significantly reduce costs and streamline processes.Specialties: FDA regulatory compliance, FDA regulatory submissions, CE Mark/Technical File development, quality system development and remediation; risk management, software, process and cleaning validations; electronic records and e-signature compliance (Part 11), ISO 9000-13485 lead auditor
Zimmer Biomet
View- Website:
- zimmerbiomet.com
- Employees:
- 18091
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Vice President Regulatory Affairs And Quality Assurance, Foot And AnkleZimmer BiometDenver, Co, Us
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Vice President Regulatory Affairs And Quality AssuranceParagon 28 Dec 2023 - PresentEnglewood, Colorado, Us -
President | FounderMeddev Compliance, Llc Jan 2016 - PresentHighlands Ranch, Co, UsRegulatory and quality assurance subject matter expert for class I, II and III medical devices. Responsible for the creation and implementation of programs to support the entire product life cycle from concept through commercialization and post-market follow-up. Expertise includes: Software and process validation, regulatory submissions, quality system remediation, quality audits, start-up assistance, quality process improvement, employee education and training. -
Vice President, Compliance, Regulatory Affairs And QualityCorelink/Sim Surgical Nov 2016 - Sep 2023Leading the implementation of regulatory and quality strategic initiatives for this growth stage manufacturer of precision surgical instruments, general orthopedic and spinal implants. Led the coordination of all FDA 510(k) submissions and all regulatory body interactions. Developed comprehensive compliance program to address 7 core requirements of OIG guidance.Key member of executive leadership team that achieved 3X sales revenue growth and 2X positive EBITDA growth over a six year period. Company acquired by Gemspring Capital in 2023.
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Vice President Of Regulatory Affairs And QualityVenaxis Inc Jul 2014 - Dec 2015Early stage IVD start-up formed to develop a test to detect acute appendicitis in the pediatric population. Direct management responsibility for Quality Assurance organization, and the implementation, maintenance of the quality management system across the company to support compliance to FDA 21 CFR Part 820 and EU IVDD. -
Director Of Quality Assurance & Regulatory Affairs / Compliance OfficerSwan Valley Medical Oct 2012 - Jul 2014Denver, Co, UsEarly stage start-up developing instrument to place SP catheters. Responsible for implementation and maintenance of quality management system; as well as establishing regulatory and healthcare reimbursement strategies for class II, sterile surgical instruments. Established company compliance program to address US and international standards of corporate conduct and ethics (Physician Payments-Sunshine Act, US FCPA, UK Bribery Act). -
Sr. Director / ConsultantMcra Llc May 2010 - Oct 2012Washington, Dc, UsResponsible for assisting client companies in tackling their most challenging quality issues including FDA issue remediation, implementation of complete quality management systems, completion of validation studies to support FDA PMA filings and European technical dossiers. -
Director Quality Systems And Regulatory AffairsMckesson 2010 - 2010Irving, Texas, UsHired to prepare the FDA submissions and lead division-wide implementation of a quality management system to support the development and marketing of new FDA regulated software products. Responsible for the development of strategic plans to implement quality and regulatory objectives for the company. -
Director, Quality SystemsMedtronic (Formally Covidien Respiratory And Monitoring Group) 2008 - 2010Responsible for the division-wide implementation of the quality management system. Authored strategic plans for division-wide quality initiatives. Led team of 2 managers and a staff of approximately 15 responsible for implementation of global supply chain quality, automated PLM systems, CAPA and configuration management. Managed an operating budget of over $4 Mil. Division management representative with respect to all FDA and Notified Body interaction.
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Head Of Quality AssuranceSynthes (Usa) 2004 - 2008Raynham, Ma, UsResponsible for the administration and coordination of processes to ensure the realization and preservation of the quality management system. Led team of 3 managers, 2 supervisors and a staff of approximately 100 responsible for product acceptance, quality engineering, supply chain quality, documentation control, and CAPA. Managed an operating budget of over $10 Mil. Management representative with respect to all FDA and Notified Body interaction. -
Manager, Corporate S/W ComplianceSynthes (Usa) 2000 - 2004Raynham, Ma, UsResponsible for the corporate-wide development, implementation and maintenance of S/W development life cycle and 21 CFR Part 11 compliance efforts.
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Sr. Quality Assurance Engineer & Regulatory Affairs SpecialistSiemens Medical Systems, Ultrasound Group 1995 - 2000Forchheim, DeResponsible for product design control, process and software validation activities; as well as managing personnel conducting product acceptance activities.
Steve Mounts Skills
Steve Mounts Education Details
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California State University, FresnoIndustrial Technology/Manufacturing Automation -
Southern Methodist UniversityGeology/Petroleum Land Mgmt
Frequently Asked Questions about Steve Mounts
What company does Steve Mounts work for?
Steve Mounts works for Zimmer Biomet
What is Steve Mounts's role at the current company?
Steve Mounts's current role is Vice President Regulatory Affairs and Quality Assurance, Foot and Ankle.
What is Steve Mounts's email address?
Steve Mounts's email address is s.****@****cal.com
What is Steve Mounts's direct phone number?
Steve Mounts's direct phone number is (888) 349*****
What schools did Steve Mounts attend?
Steve Mounts attended California State University, Fresno, Southern Methodist University.
What are some of Steve Mounts's interests?
Steve Mounts has interest in Animal Welfare.
What skills is Steve Mounts known for?
Steve Mounts has skills like Quality System, Fda, Validation, Medical Devices, Quality Assurance, Regulatory Affairs, Iso 13485, Design Control, Quality Control, Capa, V&v, Iso.
Who are Steve Mounts's colleagues?
Steve Mounts's colleagues are Alex Pitsi Mohlamonyane, William Hamilton, Ethan Seifert, Ron Skalski, Michael Peisel, Jo Theunissen, Teck Lai.
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