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|Job Category :||Engineering|
|Company Name:||RTI Surgical Inc|
|Position Name:||IT Test Engineer|
|Location :||Alachua, FL 32615|
|Job Description :||Job Title: IT Engineer, Testing Lead
Department: Information Technology
Effective Date: 2/3/2022
Location: Alachua, FL
While this is intended to be an accurate reflection of the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments).
RTI Surgical is a global, industry-leading private label OEM with expertise in allograft, xenograft, and synthetic-based implants. RTI began operations in 1998 when it spun off from the University of Florida Tissue Bank in 1998 with the goal of expanding the gift of tissue donation by pioneering tissue-based innovations that promote natural healing. Today, through integrated partnerships with customers, RTI develops and delivers restorative solutions to physicians and their patients.
As a Private Label Original Equipment Manufacturer (PLOEM) partner, RTI provides comprehensive turn-key services for development and product life cycle management in support of patients and leading medical technology companies. RTI’s implants are used in multiple surgical applications including dental, spine, sports medicine, plastic and reconstructive surgery, urology/urogynecology, and trauma.
RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on four key values:
We are accountable to each other by trusting each other’s judgment and holding each other responsible for results.
We find joy by striving to create a working environment that people enjoy.
We fully engage by focusing our hearts and minds on our customers, patients, and each other.
We adapt to change by working collaboratively to be flexible to the changing needs of our business.
RTI’s headquarters is located near Gainesville, Fla. in North Central Florida’s growing life sciences region, and has additional state-of-the-art facilities in Greenville, N.C., and Germany.
Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.
The Testing Lead is responsible for the overall system validation of all RTI existing and upcoming IT systems. The ideal candidate will have demonstrable knowledge of design and implementation of validation procedures, test plans, and test cases, 21 CFR Part 11 requirements, and the ability to coach and persuade cross-functional teams.
The candidate should have ideally worked with pharmaceutical, healthcare, or medical device manufacturer on ensuring validation services. The ideal candidate will be responsible for leading a testing team of about 3-4 members, performing validation testing, ensuring the quality of a product, documenting all required standard set of documents for testing, and working directly with the Development team & Project Managers.
Additionally, the candidate should demonstrate high degrees of competency in analysis, documentation & project management. The candidate should be able to develop, write and manage the execution of an overall software test strategy, lead efforts to enhance and make the testing process more efficient.
Assists with the development of system requirements and specifications to ensure requirements that are testable.
Tests processes like Manual testing, Smoke testing, system testing, regression testing (huge applications), UAT, Automation testing
Leads a team size of 6 to 10 people and has excellent team management skills including offshore team.
Able to interact with customers including senior leadership & business users/leaders
Documents test cases, test scripts, and test results
Diligently enters data for the collection of various metrics and KPIs and report to management
Coaches the Validation teams, in the proper execution of validation documents
Evaluates proposed changes to applications and recommend the level of validation activities required
Coordinates validation activities, protocol, and procedures, and prepare responses
Develops qualifications test protocols, traceability matrices, reports, IQ/OQ/PQ protocols, and all documents, and deliverables within the scope of the validation plan
Develops and maintains test plans, test scripts, and user acceptance tests and manage the execution of test plans
Acts as a Testing Lead for all validation projects
Executes or oversees the execution of validation plans and validation documents
Works with the overall project manager to include validation activities in implementation timelines
Knowledge of Microfocus Silk Central manual and automated testing tool
Advance SQL query writing, IIS, .net framework
Intermediate to advanced level of Excel skills
Ability to write good documents, create PowerPoint presentations and create a project plan
Bachelor’s degree in computer science, engineering, life science, or related field
8+ years experience in testing & QA, validation documentation development, using a risk-based methodology
Minimum 2 years in Pharmaceutical manufacturing or Medical Device industry experience in computer systems validation, process validation, QA or compliance functions
Excellent understanding and experience with industry regulations, Excellent interpersonal, communication, organizational, and project management skills. Excellent presentation and writing skills. Supervisory/leadership experience preferred.
Light work: Physically handle objects up to 20 lbs. occasionally.
Office Setting – Open layout with an assigned work station or office
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