Validation Engineer - Ft Lauderdale, Florida | CareerCircle
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Validation Engineer

Actalent

02/22/2022

Posting ID: JP-002663270

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Ft Lauderdale, Florida
Full Time
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Description:

The position is responsible for supporting various critical supplier quality activities and ensuring controls are in place to qualify and validate those suppliers’ products effectively. The role will support initial clinical builds of system components are conducted within design control requirements, including developing and executing Receiving Inspection activities, Component Qualification, Test Method Validation, and other Quality Control activities through final release. This position focuses on projects of moderate scope where analysis of situation or data requires a review of identifiable factors. Work closely with Product Development, Marketing, Clinical Research/Regulatory, Production and Quality Assurance to complete projects. KEY ACCOUNTABILITIES: • Develop, implement, manage, and maintain the site validation program. • Leads test method validation and verification activities. • Collaborate with QA and R&D on the qualification of current and future suppliers • Generates Design Control requirements and deliverables throughout the Product Development cycle. • Designs and implements methods and/or procedures for inspecting, testing, and evaluating the precision and accuracy of products and/or production equipment. • Supports Receiving Inspection, Product Quality Assurance and Final Release activities, including preparing documentation for inspection and testing procedures. • Writes various evaluation, verification, and validation test protocols and reports to support the product development process through design controls. • Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. • Devises new approaches to problems encountered. Independently performs most assignments with instructions as to the general results expected. • Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a major project or in a total project of moderate scope. • Conducts or supports non-conformance investigations for production. Conducts or supports CAPA-related activities for investigations. • Supports the calibration and testing program. • Supports regulatory and clinical efforts such as IDE, 501k and CE Filings.

Skills:

Validation, system validation, validation protocols

Top Skills Details:

Validation,system validation,validation protocols

Additional Skills & Qualifications:

• Minimum of a B.S degree in Engineering or Biological Science, preferably in Mechanical or Biomedical Engineering. • Minimum of 5 years of experience in manufacturing/development environments, with at least 3 years in the medical device industry. • Working knowledge of QSR, cGMP, ISO 14971, and ISO 13485. • Hands-on experience in medical device development and manufacturing. • Hands-on experience writing and executing validation protocols. • Ability to interface with regulatory bodies to present technical information. • Understand applied statistics, statistical sampling plans, and statistical process control. • Have knowledge of advance statistical methodologies such as DOE. • Software skills should include MS Word, MS Excel, MS Project and Solidworks. • Ability to perform tolerance stack-up analysis. • Experience in the development and interpretation of SOPs, Work Instructions (WIs) and engineering drawings. • Must have the ability and desire to work in a team environment. • Possess personal qualities of integrity, credibility, and commitment to RapidPulse core values. • Must have strong interpersonal, written, and oral communication, organizational, and planning skills. • Familiarity with the introduction of new products. • Must be able to effectively interface with Physicians.

Experience Level:

Expert Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Contact Information

Recruiter: Spencer Parker

Phone: +14105671334

Email: spparker@actalentservices.com

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