We found the following information about Steve Mounts at Corelink Surgical, where this person has worked as a Vice President, Compliance, Regulatory Affairs and Quality since 2016. Steve's total work experience is over 26 years, during which time Steve Mounts had at least 12 jobs at different places to develop skills. Steve Mounts studied at the California State University, Fresno from 1986 to 1989. Steve can be found in Denver, Colorado – where this expert is currently located. Find this person's current phone and email with SoftwareOfficial search.
Name variants:
Stephen Mounts
Last updated Jun 20, 2024
Contact Information
Workplace
Vice President, Compliance, Regulatory Affairs and Quality
Saint Louis, MO
Industry
Medical Devices
Colleagues
Work History
Vice President, Compliance, Regulatory Affairs and Quality
2072 Fenton Logistics Park St, Louis, MO
from Nov 2016
President | Founder
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...
from Jan 2016
Vice President of Quality Assurance
1585 south Perry St, Castle Rock, CO 80104
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 C...
Jul 2014 — Dec 2015
Director of Quality Assurance and Regulatory Affairs and Chief Compliance Officer
Responsible for implementation and maintenance of quality management system; as well as establishing regulatory and healthcare reimbursement strategies for class II, sterile surgical instrum...
Oct 1, 2012 — Jul 1, 2014
Senior Director of Quality Assurance
Responsible for assisting client companies in tackling their most challenging quality issues including FDA issue remediation, implementation of complete quality management systems, completio...
May 1, 2010 — Oct 1, 2012
Director of Quality Systems and Regulatory Affairs
3055 Lebanon Pike SUITE 1000, Nashville, TN 37214
Responsible for the division-wide implementation of a quality management system to support the development and marketing of new FDA regulated software products. Responsible for the developme...
Oct 1, 2009 — May 1, 2010
Director, Quality Systems
710 Medtronic Pkwy, Fridley, MN 55432
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 appro...
Apr 2008 — Oct 2009
Manager, Quality Assurance
325 Paramount Dr, Raynham, MA 02767
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 staf...
May 1, 2004 — Apr 1, 2008
Manager, Corporate S and W Compliance
325 Paramount Dr, Raynham, MA 02767
Responsible for the corporate-wide development, implementation and maintenance of S/W development life cycle and 21 CFR Part 11 compliance efforts.
Mar 1, 2000 — May 1, 2004
Senior Quality Assurance Engineer and Regulatory Affairs Specialist
Responsible for product design control, process and software validation activities; as well as managing personnel conducting product acceptance activities.
1995 — 2000
Senior Regulatory Affairs Specialist
35301 southeast Center St #p/o box 7018, Snoqualmie, WA 98065
Responsible for the management of all complaint handling and FDA medical device reporting (MDRs), root cause analysis, corrective and preventive action program. Assisted in the preparation a...
1992 — 1996
Supervisor, Materiel Operations
Management of receiving, production control, and internal customer service operations in four separate facilities.
Jan 1989 — Dec 1991
Education
1986 — 1989
1981 — 1983
Occupations
Executive
Chairperson
Founder
Vice President
Subject Matter Expert
IT Professional
Software Tester
Chief Executive
Founding Member
Skilled Professional
Computer Specialist
Skills
Quality System
Fda
Validation
Medical Devices
Quality Assurance
Regulatory Affairs
Iso 13485
Design Control
Quality Control
Capa
V&V
Iso
Quality Management
21 Cfr Part 11
Quality Auditing
Process Improvement
Gmp
Iso 14971
Root Cause Analysis
Computer System Validation
Lean Manufacturing
Change Control
Regulatory Submissions
Regulatory Requirements
Design of Experiments
Supplier Quality
Biomedical Engineering
Fda Gmp
Medical Device Directive
Cqa
Dmaic
Ce Marking
Complaint Management
Minitab
Cmdr
Quality Operations
Compliance Remediation
Team Leadership
Certified Lead Auditor
Value Stream Mapping
Sop
Jpal
Cleaning Validation
Electronic Signatures
Consent Decree
Public Speaking
Instructor Led Training
Risk Management
Medical Software
Healthcare Reimbursement
FAQs about Steve Mounts
What's the main profession of Steve Mounts?
Steve Mounts is a President | Founder.
What are the main profession of This expert?
These person's professions are Executive and Chairperson
Where does Steve Mounts live?
Denver, Colorado is the place where Steve Mounts lives
Does the professional have the email address?
sj**@msn.com is Steve Mounts's email address.
How many companies did Steve Mounts work at?
The professional worked at 12 jobs.
Where has Steve Mounts studied?
Steve studied at the California State University, Fresno from 1986 to 1989.
Are there any special industries Steve Mounts is connected to?
Steve Mounts works in Medical Devices industry.
Are there any professional skills, that Steve Mounts has?
Steve Mounts has skills in the following areas: Quality System, Fda, Validation, Medical Devices, Quality Assurance, Regulatory Affairs, Iso 13485, Design Control, Quality Control, Capa, V&V, and Iso.