Talent.com

Validation engineer serp_jobs.h1.location_city

serp_jobs.job_alerts.create_a_job

Validation engineer • gainesville fl

serp_jobs.last_updated.last_updated_variable_days
Sr. Engineer Quality Validation - Cleaning Validation

Sr. Engineer Quality Validation - Cleaning Validation

ExactechGainesville, FL, US
serp_jobs.job_card.full_time
serp_jobs.filters_job_card.quick_apply
The Sr Validation Engineer, QA provides leadership and cross-functional support in V&V development, planning and execution while maintaining corporate engineering and quality systems best practices...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Civil Engineer (Professional Engineer)

Civil Engineer (Professional Engineer)

GpacGainesville, Florida, United States
serp_jobs.job_card.full_time
serp_jobs.filters_job_card.quick_apply
A well-established, growing engineering firm, with a location in the area, is looking for a Professional Civil Engineer.They work hard to ensure projects are planned, designed, and managed to meet ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
City Engineer

City Engineer

City of GainesvilleGainesville, Fl
serp_jobs.job_card.full_time
This is responsible professional engineering and administrative work directing the planning, design and construction of civil engineering projects. This single position allocated to this classificat...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Validation Engineer

Validation Engineer

Katalyst HealthCares & Life SciencesGainesville, FL
serp_jobs.job_card.full_time
Protocol Review & Compliance : Study and assess Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for regulatory and procedura...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Outside Plant Engineer

Outside Plant Engineer

IQ FiberGainesville, FL, US
serp_jobs.job_card.full_time
Because the internet is now the heartbeat of our homes and an essential tool for business, it should run without interruption or stress. IQ Fiber was created to offer 100% fiber-optic high-speed int...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Chief Engineer - Hotel

Chief Engineer - Hotel

Gecko HospitalityGainesville, FL, US
serp_jobs.job_card.full_time
Chief Maintenance Engineer – Hotel Property - Gainesville, FL.You're the One Who Keeps the Lights On (Literally).We’re looking for a hands-on, take-charge Chief Engineer to lead the...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Mechanical Engineer

Mechanical Engineer

AYR WellnessGainesville, Florida
serp_jobs.job_card.full_time
AYR Wellness is a publicly traded, multi-state cannabis company with more than 85 dispensaries.We are one of the largest scale producers of high-quality cannabis in the U.People are at the heart of...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Network Engineer

Network Engineer

Seacoast National BankGainesville, FL, United States
serp_jobs.job_card.full_time
This position can be located at any Seacoast office location within the state of Florida.As a Network Engineer, you will support the design and implementation of data communications or telecommunic...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Software Engineer / Developer

Software Engineer / Developer

Redhorse CorporationGainesville, Florida, United States
serp_jobs.job_card.full_time
Now is a great time to join Redhorse Corporation.We are a solution-driven company delivering data insights and technology solutions to customers with missions critical to U.We’re looking for though...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Senior Analyst Model Validation

Senior Analyst Model Validation

VirtualVocationsGainesville, Florida, United States
serp_jobs.job_card.full_time
A company is looking for a Senior Analyst, Model Validation.Key Responsibilities Validate the performance and controls of quantitative models Identify risks and provide recommendations to mitiga...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Mechanical Engineer

Mechanical Engineer

Ayr WellnessGainesville, FL, US
serp_jobs.job_card.full_time
Mechanical Engineer Position at Ayr Wellness.AYR Wellness is a publicly traded, multi-state cannabis company with more than 85 dispensaries. We are one of the largest scale producers of high-quality...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Maintenance Engineer

Maintenance Engineer

Pyramid Global HospitalityGainesville, Florida
serp_jobs.job_card.full_time
We are seeking a Maintenance Engineer to join our engineering and facilities team.In this role, you will help ensure our hotel remains a safe, welcoming, and high-functioning environment for guests...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Manufacturing Engineer

Manufacturing Engineer

E-SolutionsGainesville, FL, US
serp_jobs.job_card.full_time
Job Location : Sarasota / Gainesville, FL.Job Type : Full Time Duration : Long term.serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
DSP Engineer

DSP Engineer

International Staffing ConsultantsGainesville, FL, US
serp_jobs.job_card.full_time
Digital Signal Processing (DSP) Engineer.Join our dynamic team in Gainesville as a Digital Signal Processing (DSP) Engineer, where you will have the opportunity to innovate and develop advanced sof...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Design Engineer

Design Engineer

CCI Systems, Inc.Gainesville, FL, US
serp_jobs.job_card.full_time +1
Employee-Owned Telecommunications Company based in Iron Mountain, MI with 60+ years of industry knowledge and experience. Our outstanding team-based work culture and environment has allowed us to gr...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Drainage Engineer

Drainage Engineer

VolkertGainesville, FL, US
serp_jobs.job_card.full_time
Are we the road to your future?.We are currently searching for an experienced.To be considered for this position, applicants musthave, at minimum, a Bachelor’s of Science in Civil Engineering.Colle...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Supplier Quality Engineer

Supplier Quality Engineer

Katalyst Healthcares & Life SciencesGainesville, FL, US
serp_jobs.job_card.full_time
Responsibilities : Knowledge of application of regulatory requirement including ISO 13485, FDA and international requirements. Enhanced quality system requirements (QSR) throughout business unit by i...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Principal Backend Engineer

Principal Backend Engineer

FeathrGainesville, Florida, United States
serp_jobs.job_card.full_time
As the Nonprofit Marketing Platform.Feathr is purpose-built to help our customers unlock more results, time, and confidence. Feathr's software marketing platform equips nonprofits with the tools the...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Automation Engineer

Automation Engineer

JLLGainesville, FL
serp_jobs.job_card.full_time
JLL empowers you to shape a brighter way.Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class services, advisory and technology f...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Software Test Engineer

Software Test Engineer

Tower Hill Insurance GroupGainesville, Florida, United States
serp_jobs.filters.remote
serp_jobs.job_card.full_time
Tower Hill Insurance Group has an exciting opportunity for a talented.Not only is Tower Hill Insurance one of Florida's most trusted names in homeowners insurance, but it offers great opportunities...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Sr. Engineer Quality Validation - Cleaning Validation

Sr. Engineer Quality Validation - Cleaning Validation

ExactechGainesville, FL, US
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
  • serp_jobs.filters_job_card.quick_apply
job_description.job_card.job_description

Description

The Sr Validation Engineer, QA provides leadership and cross-functional support in V&V development, planning and execution while maintaining corporate engineering and quality systems best practices, policies and procedures. The Sr Validation Engineer, QA is results oriented and has the knowledge and confidence in the areas of Quality Assurance and validation / verification (V&V).  This particular position has an emphasis on medical device cleaning validations.

Key Responsibilities

  • Subject Matter Expert for medical device cleaning validation for sterile and reusable devices.
  • Provide focused, technical, hands-on engineering assistance regarding V&V requirements of medical device processes, materials, equipment and methods including project management, process design, document generation (IQ, OQ, PQ, SOPs, WIs and ETSs), critical process parameter development, protocol execution and summary reports.

Projects include new product development projects, regulatory submissions, manufacturing changes, and manufacturing transfer

  • Executes activities related to the compliance of the sterility assurance program (e.g. Biocompatibility / Endotoxin testing and quarterly dose audits).
  • Generates and maintains site master validation plans.
  • Participates in the development and execution of robust inspection and test methods for V&V feasibility and qualification projects and stand alone studies.
  • Use statistical techniques, as necessary, to properly design and execute V&V activities.
  • Prepare documentation and execute V&V activities utilizing a risk based approach (pFMEA, FMEA, etc.) and Good Engineering Practices (GEPs) ensuring compliance to medical device industry regulations.
  • Coordinate personnel training, protocol and process documentation / record retrieval, as necessary, supporting timely execution and closure of all corporate V&V activities.
  • Maintain corporate validation process auditing program ensuring timely completion of auditing activities.
  • Maintain V&V planning (Validation Project Dashboard) documenting progress towards completion of corporate V&V initiatives in preparation for monthly update meetings.
  • Lead the identification, maintenance, development and enhancement of corporate systems, processes and standards.
  • Identify, analyze and correct internal and external manufacturing deviations and / or anomalies related to V&V activities ensuring optimization of production processes.
  • Successfully contribute to cross-functional project teams in all areas of device cleanliness and manufacturing V&V work such as material testing, specification development, process capability studies, research, and investigation and process / test documentation.
  • Identify and communicate significant quality and compliance concerns to the Mgr. Validations, QA and associated project team leaders early in the V&V development phase.
  • Informs Regulatory Affairs of validation projects that may require further reporting / scrutiny (e.g. PMA devices).
  • Participate in the review and qualification of external supply chain V&V activities.
  • Take primary responsibility for company-wide validation related Corrective and Preventive Actions that may result from internal / external non-conformances, recalls and / or field actions.
  • Define and lead third party, customer and regulatory audits as they pertain to validations.
  • Know and apply the Quality System and any appropriate Federal and International standards
  • Assist and support other employees, teams, and sales personnel as necessary

    • Skills Knowledge and Expertise

    Education :

  • Bachelor’s Degree from an accredited institution required; Master’s Degree preferred

    • Experience :

  • Minimum 7 years experience in the medical device industry
  • Advanced level of technical software proficiency
  • Excellent Quality System knowledge required
  • Strong time management and project management skills are necessary.
  • Experience writing IQ / OQ / PQ V&V protocols.
  • Working knowledge of principles, concepts and practices of process V&V activities, Risk Management, FDA and ISO Regulations.
  • General understanding of sterilization and related analytical testing is a plus.
  • Must be able to work independently and in a team environment.

    • Functional / Technical Knowledge, Skills and Abilities Required :

  • Statistical expertise in areas such as process capability, process assurance and sampling
  • Expertise in Microsoft Office products
  • Ability to work effectively in a team environment
  • ASQ Certifications preferred
  • Advanced level of technical software proficiency.
  • Working knowledge of statistical analysis and sampling plans.
  • Excellent communication (written and verbal) skills.
  • Excellent organization skills.

    • About Exactech

    Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit www.exac.com for more information and connect with us on LinkedIn , VuMedi , YouTube , Twitter and Instagram .