Steve Mounts Email & Phone Number

Denver, Co, Us

Englewood, Colorado, Us

Highlands Ranch, Co, Us

Regulatory 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.

Leading 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.

Early 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.

Denver, Co, Us

Early 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).

Washington, Dc, Us

Responsible 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.

Irving, Texas, Us

Hired 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.

Responsible 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.

Raynham, Ma, Us

Responsible 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.

Raynham, Ma, Us

Responsible for the corporate-wide development, implementation and maintenance of S/W development life cycle and 21 CFR Part 11 compliance efforts.

Forchheim, De

Responsible for product design control, process and software validation activities; as well as managing personnel conducting product acceptance activities.

Bs, Industrial Technology/Manufacturing Automation

Geology/Petroleum Land Mgmt