Ran Ruwan Gold Loans
Job type full-time
Full job description
Company: karl storz endoscopy-america, inc(ksea)
Job code: 11523
Pay grade: us-b15
Karl storz se & coKg based in tuttlingen, germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.
For more than 75 years, karl storz has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.
The computer systems validation and quality management specialist is responsible for executing the global non-device software validation process, in collaboration with other karl storz (ks) sites, according to global regulatory requirements and karl storz directivesThe computer systems validation and quality management specialist maintains the process’s compliance with applicable regulations and industry standards and remains up to speed on new and emerging best practices for software validationThe computer systems validation and quality management specialist coordinates, drives and supports all non-device software validation needs for manufacturing and distribution sites in north america and is thus required to collaborate with personnel of other ks sites and functionsIn this role, the computer systems validation and quality management specialist ensures that software used in the quality management system has been installed correctly, meets the user’s needs, functions accurately according to its intended use and consistently produces results that meet predetermined guidelines for compliance and quality management.
Key responsibilities include, but are not limited to:
Create and maintain the global computer systems validation process and program in collaboration with key stakeholders.
Generate and execute validation life cycle documentation such as risk assessments, test scripts, software design qualification, installation qualification, operational qualification and performance qualification reports, as required by the process.
Analyze and interpret software validation test data to determine whether the software system has met validation criteria or to identify root causes of deviations.
Identify and mitigate software problems that could negatively impact device production or quality management processes.
Perform black box testing.
Lead and coordinate all aspects of non-device software validation across multiple sites.
Provide support to the investigations of deviations and support follow-up on any corrective actions.
Create, populate, and maintain database(s) for tracking validation activities, test results, or validated systems.
Evaluate and audit software documentation and process.
Participate in harmonization of the globalizing qms.
Support continuous improvement of the qms.
Perform other duties as assigned.
IiMinimum knowledge, education and skill requirements
Minimum years of relevant work experience:
Must have a minimum of five (5) years’ experience in a medical device manufacturing qms environment.
Minimum education, certifications and/or credentials:
Associate degree of applied science
Proficiency in regulatory and quality regulations (e.g., iso 13485:2016 and fda 21 cfr 820)
Minimum hard skill requirements (including computer and application proficiency):
Familiarity with the medical device industry or other regulated industry
Subject matter expert of software validation industry standards and current regulatory environment to provide technical guidance and expertise related to regulatory compliance
Strong technical writing skills and proficient in the use of computerized office applications
Ability to manage a sharepoint site, including: create libraries, content types, lists, manage permissions, owners, and troubleshoot.
Experience in managing project timelines.
Minimum soft skill requirements:
Ability to maintain respectful and productive working relationships with co-workers and other professionals, including management.
Possess good leadership and communication skills to ensure continuous improvement of the documentation and data control system and procedures to maximize service to the qms department customers
Aware of best industry practices and processes utilizing current document and data control management tools
Preferred years of relevant work experience:
8 years’ experience in quality management systems
Preferred education, certifications and/or credentials:
Associate’s degree or equivalent work experience, relevant technical experience
Preferred hard skill requirements:
Qms subject matter expert (e.g., iso 13485:2016 and fda 21 cfr 820)
Excellent technical skills and ability to work effectively with word processing, spreadsheets and document controls software, templates and forms (visio, word, excel and powerpoint)
Capacity to read and interpret regulatory and legal documents and define the necessary compliance activities or processes
Experience in managing complex projects
Preferred soft skill requirements:
Exceptional technical writing and organizational skills, and able to multi-task and perform work accurately involving many complex tasks
Ability to express ideas clearly (both written and verbally) to a wide variety of personnel at various levels, as well as personnel at other facilities for which english may not be a first language
High level of critical thinking competency
Self-motivated, self–directed and able to work with little or no supervision
Working at karl storz during covid-19
Karl storz will continue to maintain a safe work environment for our employeesDuring the interview process, we encourage you to ask how covid-19 may impact the role you are seekingThe impact and/or company-issued personal protection equipment may vary based on the nature and location of the rolePlease click here to learn more about our response to covid-19.
Employee benefits program overview for u.sLocations
Medical / dental / vision including a state of the art wellness program and pet insurance, too!*
3 weeks’ vacation, 10 holidays plus paid sick time*
401k retirement savings plan providing a match of 60% of the employee’s first 6% contribution
Section 125 flexible spending accounts
Life, std, ltd & ltc insurance
Tuition reimbursement of up to $5,250 per year
Fitness reimbursement up to $200 annually
Employee referral program of up to $2,000 per hire
And much more!
Field sales, internships and part-time employees are not eligible except for where required by state law.
Non-employees, including temporary workers and consultants, are not eligible to participate in karl storz benefits program.
Karl storz reserves the right to change or modify the employee’s job description whether orally or in writing, at any time during the employment relationshipAdditionally, karl storz, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisorEmployee must comply will all applicable karl storz policies and procedures.
Equal employment opportunity statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran statusKarl storz is an equal opportunity employer supporting eoe/m/f/vet/disability.
If, at any point in the application process (including hiring), a candidate would like to request a reasonable accommodation due to a disability or a religious need, please email us at [email protected] and we'll be happy to engage in an interactive process with you.
Notice to employment agencies
This recruitment assignment is being managed directly by karl storz’s human resources teamHuman resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are requiredYour respect for this process is appreciatedKarl storz does not accept unsolicited agency resumesResumes received which were unsolicited by karl storz human resources department will be ineligible for referral fees.