Fernando Rea Email and Phone Number
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Fernando Rea is a Senior Staff Advanced Quality Engineer at Stryker at Stryker. He possess expertise in test method validation, test methods, engineering evaluation, process validation, process verification and 14 more skills. Colleagues describe him as "Fernando is a highly motivated individual who learns quickly. He is able to focus and prioritize project tasks and gets along well with all. He is able to communicate very well with both management level and peers.", "Fernando consistently impressed in supporting clips manufacturing without the need of a process engineer as required by other departments within Micro. As a manager, I immediately took notice to Fernando’s affinity for people. He is personable, understanding, and an effective communicator with everyone from the management team to the operators on the production floor. Fernando showed a superb understanding in seeking guidance on an as-needed basis and, many times, took it upon himself to come prepared to make the most out of our meetings. He confidently proved to be highly skilled in exercising his engineering aptitude, where he could definitively identify root cause, seek interdisciplinary expert advice, and execute towards a resolution. It was a pleasure having Fernando support the medical processing department. I am profoundly appreciative for his efforts and going the extra mile to do things right the first time. I would not hesitate to recommend Fernando for any company looking to improve their culture. Christian Huapaya Manufacturing Manager", and "I had the pleasure of working directly with Fernando at Micro in Somerset, NJ during January of 2016 through June of 2017. I found that Fernando is a competent quality engineer who is capable of handling multiple priorities with much needed attention to detail. Fernando demonstrated excellence in the areas of process validation, risk assessments, corrective action, capability assessments, equivalency studies and nonconforming material handling. During his time here at Micro, Fernando also participated in on-site FDA inspections with our team and exhibited the ability to perform extremely well under pressure. I would not hesitate to recommend Fernando to any company who is looking to add a valuable quality engineering asset who exhibits solid technical skills and the ability to perform well within a team orientated environment."
Stryker
View- Website:
- stryker.com
- Employees:
- 48790
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StrykerFlorida, United States -
Senior Staff Advanced Quality EngineerStryker Dec 2023 - PresentKalamazoo, Mi, UsDigital, Robotics and Enabling Technologies (DRE) -
Senior Staff Engineer, Design AssuranceStryker Mar 2022 - Nov 2023Kalamazoo, Mi, UsDivisional Process Owner (DPO) for Design Controls at Joint Replacement Robotics (JRR) -
Staff Engineer, Design AssuranceStryker Dec 2019 - Mar 2022Kalamazoo, Mi, Us -
Senior Quality EngineerEthicon, Inc. Jun 2017 - Nov 2019Raritan, Nj, UsSupporting New Product Introduction (NPI) and Life Cycle Management (LCM) of Biosurgery Products – Laparoscopic Portfolio Serving as a project team technical lead in all matters related to Quality Engineering Responsibilities include the following: Leading technical team to overcome challenges in design and process Developing quality strategies and validation plans for products and processes Authoring, reviewing and approving protocols and reports Participating in technical design reviews as part of Design Control activities Partnering with external suppliers as main point of contact for Quality support Supporting Quality efforts to achieve post-launch stabilization goals and objectives Maintaining compliance with FDA 21 CFR Part 820 Quality System Regulation (QSR) Examples of key deliverable support include: Component QualificationsFinished Goods SpecificationsProcess and Test Method ValidationsWork InstructionsRisk Management (pFMEA)Technical Studies (Biocompatibility, Endotoxin, Sterilization, Stability, Packaging/Transit etc.) -
Quality Assurance EngineerMicro Jan 2016 - Jun 2017Somerset, Nj, UsServed as owner of product quality in Medical Processing (MP) manufacturing and inspections of implantable endoscopic ligation clips Responsibilities included the following: Routine monitoring and improving of existing processes to increase production yields and reduce scrap using statistical process control (SPC) and engineering evaluation Quarantining potentially nonconforming product/material and performing required investigations via material review board (MRB) Establishing and executing the following requirements to fulfill supplier process change requests (SPCR) with medical device customers:Process ValidationsEquipment QualificationsRisk AssessmentsCapability AnalysesEquivalency StudiesVisual/Dimensional/Functional Testing/Inspections Coordinating/executing action items for corrective actions to address nonconformances Regularly meeting with customers to discuss and manage project progress -
Production & Process Controls Quality Engineer ConsultantGetinge Sep 2014 - Dec 2015Gothenburg, SeServed as Test Method Validation Subject Matter Expert (SME) Addressed gap assessment findings for Cardiac Surgery medical devices Responsibilities included the following: Owning CAPAs and Failure Investigation Reports (FIR) Implementing changes/improvements to existing products as a part of Design Controls Risk management – Revising FMEAs (Design, Process and Clinical) as needed Investigating Product/Process gaps with respect to Validation/Verification Conducting Process Characterizations and Feasibility Studies for Process Improvement Authoring and executing protocols to generate final reports for closure Investigating, resolving and documenting deviations with robust rationale -
Quality Engineer ConsultantSiemens Jun 2014 - Sep 2014Munich, DeManaged Project Plan for Receiving Inspection Acceptance Activities under the Quality Transformation Program (QTP) to improve batch-managed system for SAP integration Created, classified and assigned inspection plans to parts based on function and risk Refined and validated production test methods for inspecting manufactured parts -
Development Engineer ConsultantZimmer Biomet Mar 2014 - Jun 2014Warsaw, Indiana, UsDevelopment & processing of hip products under the Revision Team strictly for Design History File (DHF) RemediationReviewed and completed the following design assurance documentation for existing orthopedic instruments, Class II and Class III medical devices: Design Control Traceability Matrices (DCTM)Design Change History LogRisk Management ConfirmationStock Keeping Unit (SKU) Attribute Data ReportIdentified and closed product development gaps, which required further investigation and/or testing as part of design review -
Manufacturing Engineer ConsultantJohnson & Johnson May 2013 - Mar 2014New Brunswick, Nj, UsSupported remediation of Neurovascular Intervention Class III medical devices Developed and executed the following items for remediation and production support: Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Process VerificationTest Method Validation (TMV)Gage R&R (Repeatability & Reproducibility)Technical/Feasibility ReportsWorked closely with multiple departments (Manufacturing, Quality, Operations, R&D, Product Development etc.) to improving existing processesAuthored and improved manufacturing documents (work instructions, visual standards, etc.) Investigated and closed non-conformances (NCs) via engineering evaluation, equipment calibration, preventive maintenance, critical system changes, and operator training/certificationParticipated in Design Reviews with department functional representatives Contributed to new product development for next generation of Envoy DA Guiding CatheterSupported the facility for the following internal and external audits: Quality Systems, Microbiology & Sterilization, and FDA review of Quality Systems -
Medical ScribeEssia Health Jul 2012 - May 2013Baptist Hospital of Miami, Emergency DepartmentProvided real-time documentation of the following items using Electronic Medical Record (EMR):Patient medical historyCurrent symptomsAdmission diagnosisDischarge impressionTreatment progress including test results, notes, reports etc.Demonstrated ability to maintain patient confidentiality and privacy in accordance with governing HIPAA regulations
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ResearcherFlorida International University, Biomedical Engineering Department Jul 2011 - Apr 2012Miami, Fl, UsConcentration: Analysis of the Effects of Static Magnetic Fields on the Proliferation of Osteoblasts and Osteoclasts -
Physics Learning AssistantFlorida International University, Biomedical Engineering Department Aug 2010 - Aug 2011Miami, Fl, UsLectured physics concepts and principles to FIU studentsPerformed simulations and experimental demonstrationsDeveloped and implemented new teaching methodsParticipated in continuing physics education seminars -
TutorFlorida International University, Biomedical Engineering Department Jan 2010 - Jan 2011Miami, Fl, UsTutored students in the following subjects and respective laboratory courses:College AlgebraTrigonometryCalculusBusiness CalculusMultivariable CalculusDifferential EquationsPhysics with CalculusPhysics without CalculusGeneral ChemistryWriting & Rhetoric
Fernando Rea Skills
Fernando Rea Education Details
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Florida International UniversityBiomedical Engineering
Frequently Asked Questions about Fernando Rea
What company does Fernando Rea work for?
Fernando Rea works for Stryker
What is Fernando Rea's role at the current company?
Fernando Rea's current role is Senior Staff Advanced Quality Engineer at Stryker.
What is Fernando Rea's email address?
Fernando Rea's email address is fe****@****ker.com
What is Fernando Rea's direct phone number?
Fernando Rea's direct phone number is +178624*****
What schools did Fernando Rea attend?
Fernando Rea attended Florida International University.
What skills is Fernando Rea known for?
Fernando Rea has skills like Test Method Validation, Test Methods, Engineering Evaluation, Process Validation, Process Verification, Corrective And Preventive Action, Statistical Process Control, Biomedical Engineering, Quality Assurance, Quality System Compliance, Fda Gmp, Technical Writing.
Who are Fernando Rea's colleagues?
Fernando Rea's colleagues are Corey Cavitt, Joe Eichman, Mike Davies, Luis Nevarez, Nicole Esposito, Yurman Sanabria Diaz, Yannam Jagadeesh Reddy.
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