Quality Software Assurance Engineer Job Listing at Fresenius Medical Care in Ogden, UT

Healthcare

SUMMARY

Develop standardized methods for software validation. Perform validations for QS specific softwares. Develop system for tracking in house softwares and respective validations. Evaluate and review validation requirements for plant wide softwares. Assist in developing validation packages for plant wide softwares. Develop integration process for various data sources for quality records.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

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  Develop and establish standardized methods and procedures for software validations.
  
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  Perform software validation for QS specific softwares such as analytical instrumentation, quality system databases/softwares.
  
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  Develop SRS, SPR, etc.; perform IQ/OQ/PQ activities; and document those activities per the established procedures for QS specific softwares.
  
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  Evaluate validation requirements for each software used in various departments.
  
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  Review process software validation plans, SRS, SPR, test cases, IQ/OQ/PQ activities, etc.
  
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  Assist plant personnel/management in developing protocols, test cases, validation packages, etc. for software validations for various departments.
  
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  Design and Develop a system for tracking and cataloging in house softwares and the respective validations.
  
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  Provide guidance to maintain a system for tracking and cataloging in house softwares.
  
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  Develop, maintain, and administer data sources such as Windchill, SAP, MES, LabLink, LIMS systems.
  
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  Develop, maintain, and administer the integration process for various data sources for quality records.
  
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  Assist plant personnel/management in planning and preparing for new data sources and their respective integration for quality records.
  
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  As required, determine security, file structure, user access/interface and backup of all data and data collection systems.
  
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  Assure systems are in place to maintain compliance with QSR and ISO requirements.
  
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  Assist in maintaining/monitoring the quality of work output from department.
  
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  Maintain general housekeeping of working area and plant.
  
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  Follow all Fresenius Policies.
  
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  Regular attendance and maintaining a good attendance record is an essential function of the job.
  
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  Our Company Values: Honesty Integrity, Quality, Respect Dignity, Innovation Improvement, Teamwork Safety are the guiding principles of employee behavior at FMCNA.

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE
Master’s degree (M.S.) in science, mathematics, statistics, or other technical field with one to three (1-3) years of related experience; or Bachelor’s degree (B.S.) from a four or five-year college university in science, mathematics, statistics, or other technical field with three to five (3-5) years of related experience; or equivalent combination of education and experience.

LANGUAGE SKILLS
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

MATHEMATICAL SKILLS
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

REASONING ABILITY
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

COMPUTER SKILLS
To perform this job successfully, an individual should have knowledge of Database software; Development software; Manufacturing Software; Internet software; Inventory software; Order processing systems; Spreadsheet software and Word Processing software.

OTHER QUALIFICATIONS
Reference Appropriate Training in Compliance Wire Curriculum.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle. The employee is frequently required to talk or hear. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 100 pounds.

WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is occasionally exposed to high, precarious places. The noise level in the work environment is usually quiet.