Stephan Jones Email and Phone Number
With over 13 years of experience in quality and regulatory compliance, I am a passionate and driven leader who strives to ensure the highest standards of safety, quality, and performance for medical devices. I have a strong background in managing quality systems, conducting audits, overseeing critical suppliers, and supporting international regulatory registrations. As the Director of Quality at Allied, I am responsible for all quality compliance and conformance activities for the organization, and I work closely with cross-functional teams, customers, and regulators to achieve excellence and innovation in respiratory and emergency medical devices.In my current role, I lead a quality team and oversee quality initiatives throughout the organization, including product development, supplier management, quality agreements, change management, product release, and continuous improvement. I also serve as the lead auditor and quality contact for all domestic and international critical suppliers, ensuring their capabilities, validation, and performance meet or exceed our expectations and requirements. Some of the skills that I use and develop in my role are regulation implementation, QMS, Quality Auditing, eQMS, and team management.
Allied Medical Llc
View- Website:
- alliedmedicalllc.com
- Employees:
- 129
-
Director, Quality And RegulatoryAllied Medical Llc Feb 2024 - Present -
Director Of QualityStereotaxis Jan 2023 - Feb 2024St Louis, Missouri, Us -
Director Of QualityPharmajet Oct 2017 - Dec 2022Golden, Co, Us-Management Representative and owner of all quality compliance/conformance activities for the organization. Overseeing quality team and leading quality initiatives throughout the organization.-Lead Auditor and quality contact lead for all domestic and international Critical Supplier on-boarding and manufacturing activities. (approving quality agreements, managing relationships, guiding changes in the supply chain, establishing expectations in capabilities/validation/product release, leading audits, etc.)-MDD/MDR Technical File owner-Support international regulatory registrations/change notices/reporting as needed -
Director Of Quality And RegulatorySim Surgical Mar 2015 - Oct 2017Fenton, Mo, UsLead and represent all quality and regulatory compliance initiatives within the company (focussed in orthopedics and tissue storage/distribution)Manage multiple facility teams to maintain and exceed compliance with national and international regulations (USFDA, EEA, INVIMA, etc.), ISO standards (13485, 9001, 14971, etc.), customer expectations, and further continuous improvement in conjunction with various department leads.Executive Management team representative to customers, regulators, and standard auditing authorities. -
Facility Quality Control Supervisor/Quality EngineerSim Surgical Nov 2013 - Mar 2015Fenton, Mo, Us•CAPA Coordinator•Customer Complaint/MDR Coordinator•Nonconforming Material Coordinator/MRB member•Recall and Advisory System Coordinator•Deviation System Coordinator•Metrology System Coordinator - Gage R &R studies and calibration scheduling•Internal Audit System Coordinator•Training System Coordinator•Change Management System Coordinator•Supplier Files Management•DHR Management•Front room assistance with customer, ISO, and regulatory audits•Review and Edit SOPs, WIs, Forms, and Labels as needed•Manage 4 direct report in daily functions and team contributions•Identify and establish metrics for reporting to Management Review Meetings•Quality representative to customer for quality related concerns•Work with executive team to implement quality improvement initiatives -
Ra/Qa-Documentation SpecialistCorelink Surgical Jul 2012 - Nov 2013St. Louis, Mo, UsResponsibilities include the following (not all assignments may be listed):•Implementation of a company wide EDMS (MasterControl)•Document Management•Change Control•SOPs, WIs, Forms, and Labeling development•QMS strategy and management•Training coordinator•Customer Complaint coordinator•MDR submittals and investigations•Technical File development and management•Supplier Qualification•Medical device quality inspections•Assist in audit hosting•Assist with Risk Management process and procedures (14971) and 510(k) submission document retention•Assist coworkers in understanding and adhering to FDA, AATB, Council Directive 93/42/EEC, and ISO standards•Staying actively aware on all international Regulatory Affairs changes and news -
Quality Associate IiBaxter Healthcare/Experis 2011 - Jul 2012Deerfield, Illinois, Us•Interprets and executes policies and procedures that affect the organizational unit•Acts as a project manager to communicate with new and existing suppliers on an international platform to maintain compliance information and/or documents.•Interacts frequently with a functional peer group.•Assist team members in understanding FDA, ISO and Baxter quality requirements. •Maintains a high level of expertise in current regulatory requirements, and serves as a business resource for compliance to those requirements.•Utilized Trackwise Quality Management System for document control, audit tracking, and supplier quality monitoring based on ISO 9001 compliant processes. -
Scientist IiNormandeau Associates, Inc. May 2010 - Aug 2011Bedford, New Hampshire, Us•Played a key role in establishing detail oriented field projects that created precise results in highly developed studies for private utility companies, legal clients, state and federal regulators•Implemented key software tools for reporting critical data in reports to project managers and our clients•Data analysis/processing and documentation of field data into a company-wide filing system for verification and quality monitoring, including making sure that documenting procedures were consistent across all departments within the companyTechnician IIMay 2010 – January 2011 (9 months) •Assisted project development in studies lead for private (utility, energy, and legal), state (DOT, DEP, etc), and federal clients (EPA).•Participated in the collection and analysis of water quality monitoring, temperature surveys, tagging and tracking studies, soil quality, fish tissue sampling, and marine habitat and population data to determine precise results for small and large projects.•Also worked in lab analysis function examining collected field samples.•Promoted to a 'Scientist II' role.
Stephan Jones Education Details
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University Of New HampshireEnvironmental Sciences (Combination Of Biology And Regulation/Policy Studies) -
Whakatiwai, New ZealandAnd Sustainability -
Thompson School Of Applied SciencesBusiness Management
Frequently Asked Questions about Stephan Jones
What company does Stephan Jones work for?
Stephan Jones works for Allied Medical Llc
What is Stephan Jones's role at the current company?
Stephan Jones's current role is Director of QA/RA at Allied Medical | Leading Compliance Initiatives.
What schools did Stephan Jones attend?
Stephan Jones attended University Of New Hampshire, Whakatiwai, New Zealand, Thompson School Of Applied Sciences.
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