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Sr. Engineer Quality Validation - Cleaning Validation

Sr. Engineer Quality Validation - Cleaning Validation

ExactechGainesville, FL, US
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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
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Quality Inspector

Quality Inspector

SpherionGainesville, Florida
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Job details Spherion Gainesville, FL has a client seeking a Quality Inspector for their products.The role includes inspection of manufactured product, purchased product and the processes to ensure....serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
Software Engineer

Software Engineer

Seacoast National BankGainesville, FL, United States
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Location : This position can be located at any Seacoast office within Florida.The software engineer will play an integral role in the execution of the bank's application and API development initiati...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
City Engineer

City Engineer

City of GainesvilleGainesville, Fl
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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
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Supplier Quality Engineer

Supplier Quality Engineer

Intellectt IncGainesville, FL, US
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Job Description & Key Responsibilities : .ISO 13485, FDA, CFR 21 Part 820.CAPA closure and quality improvements.Supplier Initiated Change Requests (DCR, ECR, MCR). Supplier Audit Non-Conformities....serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_less
Remote Quality Assurance Tester - $45 per hour

Remote Quality Assurance Tester - $45 per hour

Great LionGainesville, Florida
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Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies. We guarantee 15-25 hours per week with an hourly pay of bet...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Quality Assurance Coordinator

Quality Assurance Coordinator

LifeSouthGainesville, FL
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Job Type Full-time Description.LifeSouth Community Blood Centers is currently seeking an individual to join our team as a. This position is responsible for participating in the coordination of a sys...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Quality Control Specialist - Facade

Quality Control Specialist - Facade

Tremco RoofingGainesville, FL, United States
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The Quality Control Specialist educates WTI personnel on the proper use and application of products, providing installation training both on and off the roof. They oversee large self-performed proje...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Quality Engineer

Quality Engineer

VirtualVocationsGainesville, Florida, United States
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A company is looking for a Quality Engineer III.Key Responsibilities Develop and execute software quality methods and processes, including test plans and documentation Lead projects and mentor j...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Quality Assurance Engineer Coordinator

Quality Assurance Engineer Coordinator

University of FloridaGainesville, Florida, USA
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Classification Minimum Requirements : .Associates degree and two years of relevant experience; or a high school diploma or equivalent and four years of relevant experience. Appropriate college coursew...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
Quality Assurance Auditor - Jacksonville, FL

Quality Assurance Auditor - Jacksonville, FL

AvmaxFL, USA
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Quality Inspector @ Gainesville, Florida (1099 Contractor)

Quality Inspector @ Gainesville, Florida (1099 Contractor)

Pro QC International North AmericaGainesville, FL, US
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Supervise and audit truck loading / unloading of 20–40 wooden book carts per truck.Verify compliance with Google’s packing / handling instructions at pickup library sites. Observe loading process, docum...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Quality Control Inspector - Glass Family of Companies

Quality Control Inspector - Glass Family of Companies

G.A.S. GlobalGainesville, FL
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Our client develops, manufactures, markets, distributes, and sells orthopedic implant devices, related surgical instrumentation, and biologic services. Many of the roles are temp to hire with our cl...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Software Engineer

Software Engineer

Seacoast BankGainesville, FL , US
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Location : This position can be located at any Seacoast office within Florida.The software engineer will play an integral role in the execution of the bank’s application and API development initiati...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Supplier Quality Engineer

Supplier Quality Engineer

Katalyst HealthCares & Life SciencesGainesville, FL
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Knowledge of application of Regulatory requirement including ISO , FDA and International requirements.Enhanced quality system requirements (QSR) throughout business unit by improving quality proces...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Quality Control Inspector

Quality Control Inspector

Fox FactoryGainesville (Machine Shop), US
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Inspects finished products, products being processed, incoming materials, parts and assemblies, etc for conformance to company standards. Checks randomly selected samples and verifies accuracy of eq...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
In-Home Sales Representative- Quality Craftsmen

In-Home Sales Representative- Quality Craftsmen

Luxury Bath TechnologiesGainesville, FL, US
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In-Home Sales Representative Join our growing team here at Quality Craftsmen Are you looking to work for the best in the business?. Quality Craftsmen is a rapidly growing acrylic bath remodeler in t...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Manufacturing Engineer / validation process engineer

Manufacturing Engineer / validation process engineer

cGxPServeGainesville, Florida, USA
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Protocol Review & Compliance : Study and assess Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols and reports for regulatory and procedural ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
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Roadway Engineer

Roadway Engineer

Kimley-HornGainesville, FL, US
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Civil Engineer Job In Ocala, Fl.Kimley-Horn's Ocala, FL office is seeking a Civil Engineer with 4+ years of experience to join their Roadway team! This is not a remote position.Collaborate with the...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
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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 .