Monster
 
 
 
 

Job Summary

Location
Cincinatti, OH 45215
Industries
Manufacturing - Other
Healthcare Services
Medical Devices and Supplies
Job Type
Full Time
Employee
Years of Experience
2+ to 5 Years
Education Level
Bachelor's Degree
Career Level
Experienced (Non-Manager)
Salary

Commensurate with Experience
Job Reference Code
09-0435-B

IT Compliance & Controls Specialist

About the Job


IT Compliance and Controls Specialist

Hill-Rom Holdings, Inc. is the parent company for Hill-Rom’s operations and has been a leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, and information technology solutions since 1929.


Hill-Rom Holdings, Inc. (NYSE:HRC) currently employs more than 6,500 people worldwide, including approximately 2,000 at its global headquarters. Our mission is simple: Everyday we strive to make a positive difference in the lives of patients and those who care for them.


Hill-Rom offers its associates challenging work experiences, a collaborative team environment, and an atmosphere to continually develop your career. However, the strongest reason for working at Hill-Rom is the opportunity to put your passion for making a difference to work.


We are currently seeking an IT Compliance and Controls Specialist for our Batesville, IN office. We offer an excellent compensation package and comprehensive benefits, including: competitive salary, 401K, Medical, Dental, Vision, Life Insurance and tuition reimbursement.


JOB SUMMARY: The IT Compliance and Controls Specialist will be responsible for ensuring that our systems meet the highest standards in quality and compliance. Joining our Information Technology team in Batesville, IN to provide guidance within our Information Technology Department globally. Responsible for the management and governance of computer validation and compliance related activities. This includes responsibility for the IT change control process, assess IT risks and participating in FDA, SOX, and internal audits.


ESSENTIAL DUTIES AND RESPONSIBILITIES:


  • Execution and management of the change control system. This includes identification and execution of system improvements, review of validation and qualification protocols ensuring compliance changes that apply to application and infrastructure . Review and approval of High Risk Change Requests and producing monthly metrics for reporting purposes. •

  • Assess the company’s IT risks, oversee the testing procedures related to all aspects of our IT environment. Identify and evaluate issues or deficiencies, recommend improvement and action plans, solicit feedback, and maintain the IT Master Validation Plan.

  • Assist in establishment of internal company documentation (SOPs) relating to computer validation and change control activities, ensure all IT associates are trained on the SOPs and training records for IT are up to date and accurate, and ensure compliancy.

  • Maintain internal IT Change Control procedures providing review of applicable changes.

  • Conduct periodic reviews on relevant systems and validation documents.

  • Maintain documentation library for computer system validation.

  • Key point of contact with IT external and internal auditors, assist them to conduct yearly IT SOX audits, FDA audits and internal audits. Find and drive efficiencies in the process.

  • Documents, reviews, tests, and assesses IT and operations reporting processes and controls.

  • Monitors reported IT issues and deficiencies, including follow up and validation of management actions. Takes corrective action where necessary.

  • Provide insight and expertise on best practices in software quality.

  • Provides technical consulting and project management functions as required.



    • Qualifications

    EDUCATION AND/OR EXPERIENCE REQUIRED:

  • B.S. and/or M.S. Degree in computer science or accounting (with an emphasis on auditing)
  • 3 -5 years of relevant experience in a regulated industry, such as medical, consumer or industrial fields
  • 1-3 years of hands-on experience in software validation or development for regulated systems (non-product)
  • Knowledge of FDA requirements for the intended use validation of automated testing for medical device software
  • Understanding of the software development life cycle; FDA/ISO regulations for software development
  • ITIL Certification a plus
  • Remedy Change Management a plus
  • Audit experience a plus
  • Proven effective leadership competencies including team player, good communication skills, change agent, strategic thinker, good interpersonal and relationship skills, and ability to work with minimum supervision

    At Hill-Rom, we strive to build a diverse work force through equal opportunity employment that embraces and leverages the differences each individual has to offer.

    M/F/D/V

    NOTICE: All applicants receiving offers of employment will be required to pass a drug screen and criminal background check as a condition of hire. It is the policy of the Company to maintain a safe workplace free of the influence of illegal drugs and to vigorously comply with the requirements of the Drug Free Workplace Act of 1988.




    •  
     

    Job Tools

     

      Search for more jobs