Mike Gomez's Location
Rohnert Park, California, United States, United States
Mike Gomez's Contact Details
Mike Gomez work email
- Valid
- Valid
- Valid
- Valid
- Valid
Mike Gomez personal email
n/a
Mike Gomez phone numbers
About Mike Gomez
Experienced Quality Executive with thirty years of medical device experience in Therapeutics and Diagnostics including LDT’s. Skilled in writing, implementing, and maintaining complete quality management systems compliant to ISO 13485 (EU QMS), title 21 CFR 820 (FDA QSR) and title 42 CFR 493.1200-1299 (CLIA Lab QMS).
Mike Gomez's Current Company Details
Director of Quality for Production and Design
Mike Gomez Work Experience Details
-
Director Of Quality For Production And DesignNeilmed Pharmaceuticals Sep 2023 - Oct 2024Santa Rosa, Ca, UsOversight of quality for production at the corporate headquarters and our Southern California facility. -
Head Of Quality And RegulatorySimple Healthkit Jan 2023 - Aug 2023Fremont, Ca, Us -
Head/Sr Director, Global Quality AssurancePredicine Sep 2021 - Dec 2022Hayward, Ca, Us• Implement and maintain the company’s global Quality Management System (QMS), which includes FDA’s QSR (21 CFR Part 820) and ISO 13485.• Supports Quality Assurance areas related to design, manufacturing, process control, product reliability, software, design and development.• Ensure quality compliance with national and international standards and legislation.• Support supplier management of critical suppliers including testing services, reagent suppliers, and manufacturers.• Perform receiving, in-process, first article verification of labeling, laboratory reagent sampling and final inspections to determine conformance with product specifications.• Coordinate and conduct testing outlined in protocols and test methods for production products or laboratory processes.• Provide Quality leadership for cross functional projects including determining QA timelines, plans and strategies.• Monitor performance of the QMS and advise senior management during management reviews.• Create and review regulated documents associated with the design and manufacture of medical device products such as SOPs, specifications, laboratory protocols and reports, quality control and reliability plans. • Manage all quality training for the company including determining training needs in line with current policies and regulations.• Support the QMS as part of quality including customer complaint handling and processing of returned goods, documentation, and feedback to the other departments.• Provide quality perspective in support of design control and change control activities. • Support the construction of a Design History File with guidance from the Quality Director. • Provide support in generating a quality system to support the CLIA/CAP functionality of the Laboratory, as well as maintain and insure compliance to regulations, laws and company policies. All work performed in this role will follow local, federal and state regulations including CAP and CLIA. -
Sr. Manager Quality AssuranceCaredx, Inc. Jun 2021 - Oct 2021Brisbane, California, UsEstablish and implement product (reagents/instrument/software) related quality requirements and advise cross-functional project teams on Design control documentation and quality considerations for the assigned projects.Ensure generation of documentation for submission to regulatory agencies in conjunction with Regulatory AffairsPlay a leading role in defining the quality strategy to support product commercializationSupport and manage a Quality Management System compliant to CLIA/CAP/QSRDrive the development and monitoring of Quality System processes, including but not limited to Management responsibility, quality audits, personnel, design control, purchasing controls, CAPAs and complaints.Maintain the Internal Quality Audit system and perform periodic internal audits of the quality management systemGenerate audit / assessment reports/trending analyses, including follow through proposals for resolutionConduct supplier assessment audits/surveys for CareDx approved supplier lists for materials, equipment and services.Manage CAPA system; coordinate MDR investigations; interact with all key internal customersSupport the electronic Document Control system to assure compliance to in house and/or external specifications and regulations and to ensure and manage a Quality related training program for employeesProvide strategic direction and consultative support to the business unit and other personnel related to Quality System RequirementsDefine the development and review of Standard Operating Procedures and policy guidelines for the QA department.Provide as necessary regular Quality updates to the Executive group, and Operations -
Quality Leader (Medical Device)Ripple Llc Dec 2019 - Mar 2021Salt Lake City, Ut, Us• Lead and encourage professional development of the Quality Team • Inspire everyone at Ripple in the virtues of Quality • Lead and participate in SOP generation and rollout • Train company in all aspects of QMS and Operating in Medical Device Industry • Prepare QMS for 3rd Party Certification • Management Representative and Lead for all Third Party Audits (ISO, FDA, PMDA, etc.)• Sustain and improve QMS• Help prepare 510(k) submissions • Help develop culture of the company -
Senior ConsultantOriel Stat A Matrix Jan 2018 - Mar 2021Oriel STAT A MATRIX helps organizations reduce costs and risk by achieving compliance with global regulations and improving business processes. The companys consultants and trainers provide a full range of RA/QA, Lean Six Sigma, and Performance Improvement training, coaching, and consulting support around the world.
-
Director Of QualityArcherdx, Inc. Jan 2018 - Nov 2019Lead the QA function to ensure quality system development, activities, and programs related to product development and manufacturing activities such as maintaining ISO 13485 certification, compliance with cGMP, FDA and other relevant regulations.Subject matter expert for the evaluation, prioritization, and communication of quality issues relevant to corporate goals including serving as Management Representative, providing regular reports to executive management for management review meetings and participating on project teams and/or working groups, as required.Support business-wide quality assurance by working with appropriate team members to develop and enforce policies and proceduresDelivery of strategic plans and written and verbal communication with regulatory agencies (US and global)Manage Quality and Regulatory department personnelEnsure delivery against Quality departmental goals and objectives through accurate planning of activities, budgets, and resourcesDevelop, oversee, and provide corporate quality training such as GMP trainingEnsure the successful development, implementation, and administration of a system for Quality documentation and controlled records including standard operation policies and proceduresDirect/Oversee internal and external audits and inspections, draft audit reports, and delivery on required actionsManage maintenance of Quality Systems (deviations, non-conformance, corrective and preventative actions, document and supplier control, etc)Perform other duties as assigned by supervisor
-
Medical Device Principal ConsultantMed Dev Quality Consulting Llc Feb 2017 - Jan 2018Medical device quality engineering consulting for the therapeutics and diagnostics industries.Quality management system authoring (national and international).Quality management system auditing. Remediation for risk management processes, design history files, technical data files, verification and validation activities.Supplier quality support. Corrective and preventative action support. 25 years of experience from start-ups to Fortune 500 companies.
-
Medical Device Quality Engineering ConsultantOxford International Oct 2017 - Dec 2017Beverly, Massachusetts, UsGap analysis and quality system remediation/ implementation. -
Medical Device Quality Engineering ConsultantAlku Jan 2017 - Jun 2017Andover, Ma, UsWorking as a supplier quality engineer.PFMEA remediation to ISO 14971NCR’s and CAPA’s processing and closureSupporting various supplier quality initiatives for the company’s base business. -
Medical Device Quality Engineering ConsultantRedbock Sep 2016 - Nov 2016Encinitas, California, UsTechnical quality system remediation based on corrective and preventative action observations, documentation review and change orders. Working with SME's and a project teams as required. Evaluation of risk and impact of remediation based on multiple facility locations and multiple product lines. Corrective and preventative actions to be executed and implemented corporate wide. -
Medical Device Quality Lead And Project ManagerBlack Diamond Networks Apr 2015 - Aug 2016Andover, Massachusetts, UsTechnical quality lead engineer and project manager responsible for establishing a controlled environment production area. Process validation of a class II device for neurological applications. Risk assessment and/or root cause investigation for legacy issues. Sustaining support of the product and design changes to support its integration into the parent companies product portfolio. Managing direct reports as required. -
Product Development And Quality EngineerBiodesix, Inc. Jan 2014 - Feb 2015Louisville, Colorado, UsPreparation of regulatory filings, reporting, and all other aspects associated with the requirements of introducing and maintaining products on the market in the US, Europe, and beyond. Work closely with the product development, laboratory operations, statistics, and clinical development teams to develop clinical laboratory products pursuant to the quality management system processes (under design control) that lead to the successful preparation, submission to, and approval of our products. Lead quality representative for the design control process on the companion diagnostic core team (Proteomics). -
Staff Design Quality EngineerRoche Oct 2008 - Dec 2013Switzerland 🇨🇭 , ChQuality engineering support for new IVD products from development to product launch. Development quality support for regulatory audits. Lead quality representative for the design control process on the companion diagnostic core team (HER-2, Chr 17 probe). -
Senior Design Quality EngineerVentana Medical Systems Dec 2004 - Oct 2008Tucson, Arizona, UsQuality engineering support for new IVD products from development to product launch for instruments, software, antibodies, probes, detection chemistries, special stains and primary stains(H&E). Development quality support for regulatory audits. Lead quality representative for the design control process on the companion diagnostic core team (HER-2 antibody). -
Senior Corporate Projects ManagerMdmi Technologies Nov 2002 - Sep 2004Lead consultant responsible for all aspects of Quality Engineering. Head of special projects. Also worked as interim head of Quality and Manufacturing. Managed the quality and manufacturing department and establish the annual operating budget for my tenure. Management representative for the notified body. Production support of a PTCA catheter and an thermal endometrial oblation device.
-
Principal Process/Validation ConsultantMicromed Laboratories Jul 2001 - Oct 2002UsQuality Engineering Consultant. Supported remediation of an intervascular ultrasound machine. Prepared all documentation to support corrective actions for design history file deficiency. Supported design changes to an implantable insulin pump. -
Development And Manufacturing EngineerMedtronic Vascular Nov 2000 - Jul 2001Minneapolis, Mn, UsManufacturing Engineer for the AnueRx endovascular prosthetic delivery catheter. Support production transfer post acquisition to the Medtronic facility. -
Associate Development And Manufacturing EngineerMedtronic Vascular Jul 1997 - Nov 2000Minneapolis, Mn, UsManufacturing engineer for the iliac and renal stent production lines. Fabricated/machined jig and fixtures for production support. Redesigned a renal stent that was submitted to the FDA and was approved.
-
Development And Manufacturing Engineering Technician IiiMedtronic Vascular Jul 1995 - Jul 1997Minneapolis, Mn, UsEngineering support for the coranary stent production lines on 2nd shift. Primary SEM technician for metallurgical examination of stainless steel stents for production support and failure investigation.
-
Quality Systems EngineerDevices For Vascular Intervention Inc. Mar 1992 - Jul 1995Quality systems support for all R&D and production line for a directional coronary atherectomy device. Was also management representative for the notified body.
Mike Gomez Skills
Quality System
Fda
Design Control
Quality Control
Iso 13485
Medical Devices
Validation
Gmp
V&v
Capa
Manufacturing Engineering
21 Cfr Part 11
Manufacturing
Technology Transfer
U.s. Food And Drug Administration
Product Development
Regulatory Affairs
Iso
Management
Biotechnology
Iso 14971
21 Cfr
Design Of Experiments
Root Cause Analysis
Quality Auditing
Life Sciences
Corrective And Preventive Action
Verification And Validation
Medical Diagnostics
Quality Engineering
Quality Systems
Process Development
Process Validation
Fmea
Diagnostics
Problem Solving
Validations
Quality Assurance
Product Launch
Mike Gomez Education Details
-
University Of Northern California MarinBiomedical/Medical Engineering -
Santa Rosa Junior CollegeMetallurgical Engineering And Machining
-
Palmor Community CollegeQuality Assurance Technology.
Frequently Asked Questions about Mike Gomez
What is Mike Gomez's role at the current company?
Mike Gomez's current role is Director of Quality for Production and Design.
What is Mike Gomez's email address?
Mike Gomez's email address is go****@****ine.com
What is Mike Gomez's direct phone number?
Mike Gomez's direct phone number is +152020*****
What schools did Mike Gomez attend?
Mike Gomez attended University Of Northern California Marin, Santa Rosa Junior College, Palmor Community College.
What skills is Mike Gomez known for?
Mike Gomez has skills like Quality System, Fda, Design Control, Quality Control, Iso 13485, Medical Devices, Validation, Gmp, V&v, Capa, Manufacturing Engineering, 21 Cfr Part 11.
Free Chrome Extension
Find emails, phones & company data instantly
Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Aero Online
Your AI prospecting assistant
Select data to include:
Total price:
$0.00
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial