Jon Saltonstall is Senior Vice President of Regulatory and Quality Compliance at AlvaMed. Jon has more than 25 years of hands-on experience developing sterile, single use catheters, disposables and implants. Jon has held quality assurance leadership roles in several startup companies from pre-clinical to early-stage commercial. He has expertise in quality system design and implementation as well as design controls, risk management and manufacturing transfer. Jon also has extensive experience working in contract R&D and manufacturing environments. Jon is a detail-oriented problem solver capable of working independently or as part of large cross functional teams. He has a unique ability to distill complex problems into simpler, actionable tasks. He believes in providing risk-based options to clients, allowing them to choose solutions that best fit their business needs and risk tolerance.
Jon’s accomplishments include the following:
Quality Systems
- Installed and maintained nimble FDA/ISO/MDR compliant quality systems at multiple startups that led to FDA device approvals, OUS clinical trial approvals and CE Mark approvals.
- Developed procedures that embrace a commonsense approach to quality: balancing compliance and flexibility. This allows companies to move rapidly through the development process, while producing high quality products and documentation.
- Provided subject matter expertise to large company QMS harmonization projects.
- Experienced internal auditor and external audit host/coordinator with long history of successful federal, state and Notified Body audits and inspections.
- Performed core QMS activities including:
- CAPA investigation, root cause analysis, resolution, and effectiveness checks;
- Complaint investigation, MDR and vigilance reporting; and,
- Management Review preparation, execution and follow up.
Design and Manufacturing
- Served as Acting Head of QA (including Management Representative) on behalf of several virtual companies, including oversight of contract design/manufacturers.
- Developed product specifications and corresponding design verification methods for mechanical devices, catheters, and implants.
- Led risk management activities in compliance with ISO 14971 including hazard analysis, design, and process FMEA, postproduction risk management activities.
- Designed and executed strategies for biocompatibility testing, ethylene oxide and gamma sterilization validation, packaging/transit validation, aging validation.
- Performed equipment IQ/OQ/PQ, calibration, maintenance, and monitoring.
- Performed production QA activities such as inspection and sampling plans, training, batch records, and scale up.
In addition to his core competency in quality systems and quality engineering, Jon also has complementary experience supporting Regulatory Affairs including:
- 510(k) and IDE writing, submission, additional information strategy and responses.
- Writing of technical documentation that resulted in CE Mark approval and Canadian Medical Device Licensing.
- Authoring clinical trial application and investigator’s brochure to support approval of OUS clinical trials.
Jon holds a B.S. in mechanical engineering from Northeastern University.
