David Schoenhals, Cqa Pcqi Fsvpqi Email & Phone Number

Salt Lake City, Ut, Us

Salt Lake City, Utah, Us

Responsible for all Quality Operations and Quality Teams on-site ensuring product conformance and compliance. Ensure the company is compliant with state and federal regulations specifically related to Dietary Supplement GMPs and Cosmetic regulations. Quality Operations Management:Resource managementVendor Qualification and Incoming Inspection Programs (product inspections, testing, batch record reviews).In-Process Inspections and Batch Record Management.Document Control, Sanitation, Environmental Testing, and Mock Recall Programs.Specification Control, Change Management, and Deviation/Nonconformance activities, including material reviews and quarantines.CAPA, Product Complaint, and Risk Assessment Programs (stability, safety, packaging compatibility).Internal Audits and Equipment Calibration.Allergen, Pest Control, and GMP Personnel Programs.Certifications & Customer Requirements:Maintain NSF, ISO and other certifications and compliance with customer-specific programs (e.g., Tested to be Trusted, Amazon, Costco, Walgreens and CVS).Continuous Improvement:Enhance GMP programs, ensuring high-quality standards across operations and personnel.Improve operations efficiency through CI initiatives.Training and education of employees to build employee opportunities for growth.

Austin, Texas, Us

Manage the full life cycle of Supplier Qualification audit program for Dietary Supplement (21 CFR111) and Energy Drinks (21 CFR 117)Create Risk Based Supplier Assessment program for Food Safety and Dietary Supplements to ensure compliance to FDA regulatory requirements and the GFSI Food Safety schemesDevelop an effective Supplier and Audit qualification strategy and process to meet changing regulatory landscape for Dietary Supplements and Energy Drinks in a fast moving industry Manage and streamline CAPA and SCAR (Supplier Corrective Action Request) process to improve and build robust supplier relationships for improved product conformityPartner with Contract Manufacturing Organizations to perform investigations and root cause analysis for non conformities and support mitigation and corrective actions plans to improve supplier performance.Mentor, train, educate and develop Supplier Quality Assurance staff membersLead process improvement activities to streamline critical cross-functional programs for product release, warehousing, product returns, and Support Quality objectives in special projects such as registering with CFIA, Health Canada, liaise with NSF, LGC and others.Support Cross functional teams for Strategic Sourcing, Product Development, and Logistics

Salt Lake City, Utah, Us

Audit Leadership & Compliance:Lead and conduct product, process, supplier, and internal quality audits to ensure compliance with corporate and regulatory cGMP standards.Develop and manage risk-based audit schedules for raw materials and contract manufacturers.Facilitate risk assessment meetings to evaluate raw materials, suppliers, and processes for regulatory compliance.Coordinate corrective actions in response to internal/external audits and regulatory inspections.Support Quality Management during regulatory agency inspections.Supplier Quality & Problem Resolution:Oversee the supplier qualification program, conducting investigations and resolving quality-related product and process issues.Lead external quality systems audits for raw material and contract manufacturers.Quality Assurance & System Development:Execute routine quality assurance tasks to maintain cGMP compliance and ensure product quality and specification conformity.Develop and refine the company’s quality assurance system to meet cGMP and quality system requirements.Specialized Roles & Certifications:Act as a Preventive Controls Qualified Individual (PCQI) and oversee the Foreign Supplier Verification Program (FSVP).

Slough, Berkshire, Gb

Supplier Quality Management:Develop, implement, and optimize supplier assessment and re-approval processes.Establish and oversee supplier quality agreements ensuring compliance with regulations.Monitor supplier quality performance, conducting routine audits and managing corrective action plans.Collaborate with Procurement, Operations, and Quality teams to resolve supplier-related quality issues affecting safety, compliance, and performance.Ensure supplier adherence to cGMP standards and regulatory requirements (21 CFR 111, 210, 211, ICH Q7, MHRA).Drive supplier improvements to enhance product quality, operational performance, and regulatory compliance.Regulatory Compliance & Quality Systems:Lead site validation activities, including SAP implementation and software regression testing.Maintain and administer quality systems (Trackwise, MasterControl, Starlims), generating and analyzing compliance trends (Deviations, CAPA, Change Controls, Complaints).Support internal and external audits, ensuring timely investigation, CAPA implementation, and audit closure.Train employees on cGMP standards and regulatory compliance requirements.Change Management & Continuous Improvement:Facilitate change control processes and root cause investigations for non-conformances.Verify implementation and effectiveness of corrective and preventive actions.Stay updated on regulatory trends, adapting supplier qualification strategies as needed.

Palo Alto, Ca, Us

Varian Medical Systems is the world's leading manufacturer of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, proton therapy, and brachytherapy. The company supplies informatics software for managing comprehensive cancer clinics, radiotherapy centers, and medical oncology practices. Varian is a premier supplier of tubes and digital detectors for X-ray imaging in medical, scientific, and industrial applications and also supplies X-ray imaging products for cargo screening and industrial inspection.Regulatory Responsibilities include:-Maintain vigilance of current regulatory requirements: Monitor and maintain current knowledge of regulatory requirements impacting applicable medical devices. Assess and approve product change controls for continued compliance to standards.-Submit Documents: Submit documents to appropriate authorities to be apostilled, legalized and notarized to address customer requests for certified documents.-Respond to Document Requests: Update and create Certificate of Foreign Government on the FDA CECATS system. Fulfill requests for Declaration of Conformity (CE mark for MDD/RoHS) and Notified Body Certificates for ISO 13845, ISO 9001 and ISO 14971.-File Supplemental Reports: Coordinate with document owners to compile document packages to submit supplemental reports to the FDA on eSubmitter and file supplemental reports for product safety with Underwriters Laboratory (UL).-Update and Manage: Ensure functionality and verify mapping of the technical file index for all products and add new products to the technical file index.-Review and Revise: Coordinate with Change management and Document Control to update regulatory affairs SOP’s to reflect current or best practice. In addition review and submit labeling and documentation change request to address regional requirements.

Trident Manufacturing, a subsidiary of Probe Manufacturing (http://probeglobal.com), is a small contract manufacturer specializing in electronics. Trident provides small and mid-level companies the ability to out source their manufacturing needs. My responsibilities at Trident include running all operations in the Surface Mount Technology department. Critical processes include programming the SMT (CNC) machines, setup, production, auditing, documentation and initial quality inspection. I am responsible for solving all issues including documentation discrepancies, parts, supplies, programming, mechanical failures and maintenance. I coordinate with upline departments for scheduling and confirmation of audited kits and downline departments to adjust workflow to Touch-up, Through-hole and final inspection.-All Surface Mount activities including: Supervising up to 4 employeesInitial Quality inspection of all surface mount productsDirecting workflow and assigning dutiesCreation of all SMT ProgramsSoftware used - GC Prevue, MS Excel, Universal Platform V4.5.0-Initial set up of SMT (CNC) machines for all production runs: Loading, modifying programs while live on the production lineOptimizing multiple SMT (CNC) machines to maximize efficiency -Verification:Documentation- BOM, sales orders, parts list and certificatesCustomer parts list/Vendor parts list Gerber files and placements/rotationsStencilsPCB panels, Revision, panelization -Maintaining parts database:Adding new parts/package sizesEditing and modifying existing parts/package sizesProblem solving/correction of database-Technical Support for SMT (CNC) machinesRepair of mechanical failuresAddressing/solving error codesPreventive maintenanceDocumentation ISO 9000 and IPC standards

Salt Lake City, Ut, Us

-Professional Development:Knowledge and compliance with regulatory bodies.Authored online training modules.Created and instructed company wide live training seminars.Instructed weekly new employee classes, including hands-on training.Met with department supervisors and managers to determine training requirements.Audited training files and migrated hardcopy files to electronic tracking (MasterControl.) Technical Trainer: technical training responsibilities as it pertained to new lab staff.General knowledge and instruction for new employees regarding: ISO 17024, ISO 9001, ISO 13485, 21 CFR 58 GLP, 21 CFR 820 med device, 21 CFR 211 pharma, 21 CFR 1271 tissue Aseptic techniques, sterile gloving, instrument wrap, placement of items in a laminar airflow hood (Biological Safety Cabinets and Chemical Fume Hoods), reducing risk for cross contamination, placement and unwrapping instruments, and analyst techniques. -Laboratory Analyst: Packaging Department: Responsible for using various methods to check package integrity for medical device or pharmaceutical products. Including sealed vacuum chamber testing, tensile Strength testing, pressure leak testing, BI strip testing/validation, pour plating, and plate counting. Ethylene Oxide Sterilization Department: Sterilization services for devices in clinical trials, determining EO concentrations, sterilization pressures, times and temperatures to ensure kill cycles. Including Process Challenge Device (PCD) preparation, operating EO sterilization chambers, inoculation of sutures or wires for direct challenge of Medical devices, determining most resistant location for PCD placement and sterile transfers of PCD's. Hospital Reprocessing Department: Validation of cleaning cycles for reusable medical devices or instruments. Including cleaning validations for manual cleaning and steam sterilizers cycles, operation of steam sterilizers, microorganism cultivation, spread plating, plate counting, diluting back solutions.

Tel-Aviv, Il

Bachelors Of Science, Exercise And Sport Science

Graduate Certificate, Regulatory Affairs For Life Sciences