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Job Title:  Quality & Regulatory Compliance Specialist

Req ID:  22010
Job Category:  Regulatory Affairs
Country/Region:  US
State:  OH
City:  Mentor
Zip:  44060
Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

The mission of the STERIS Quality & Regulatory Compliance function is to implement repeatable and sustainable processes to ensure on-going compliance with domestic and international regulations and standards.  This includes evaluating the relevance to all STERIS facilities and products and implementing efficient and effective processes to ensure adherence to applicable regulations and standards. The compliance activities require close work with STERIS corporate domestic and international staff, Customers, Notified Bodies, and U.S and foreign government agencies. 

What You Will Do
  • Responsible for assembling product and Customer data concerning product corrections, removals and field upgrades, tracking of Customer notifications and Field Service repairs, and maintenance of correction documentation.
  • Responsible for investigating complaints for potential reporting under the FDA Medical Device Reporting regulations, preparing draft complaint summaries and MDR reports for presentation to the Reportable Events Committee for review and maintaining documentation in accordance with department policies, procedures, and work instructions. 
  • Provide support to the Director, Quality & Regulatory Compliance in the development, enhancement, standardization, execution and implementation of processes to manage the notified body audit program.  Support includes coordination of facility audit scheduling and issue resolution. 
  • Support execution of the supplier quality program, including, qualifications and/or audits, routine monitoring, assessment meetings, action requests and as necessary, issue resolution.
  • Participate in quality system audits at global facilities as requested. 
  • Provide support to the Quality & Regulatory Compliance team in the investigation and resolution of global CAPAs.
  • At the direction of the Director, Quality and Regulatory Compliance, support FDA and other regulatory agency responses following receipt of formal observations.
  • Track corrective action activities for external audit observations and obtain and review objective evidence as actions are completed in accordance with prescribed commitments.
  • Conduct yourself in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies.
  • Perform data analysis/trending as requested. 
  • Support continuous improvement efforts within the facility and the organization through participating in quality and performance improvement projects as requested. 
What You Need to be Successful
  • Bachelor's Degree required, preferably with scientific, engineering, regulatory, internal audit, or general business core concentration
  • No specific work experience is required as this is an entry-level position
  • Self-starter that is highly organized.  
  • Strong oral and written communication skills.
  • Ability to balance multiple high priority responsibilities on-time and effectively.
  • Ability to perform assigned tasks in a highly complex environment.      
  • Excellent PC skills, including Microsoft Office applications.
  • Strong interpersonal skills

 

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Offering You in Return

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.

 

STERIS is a $3B, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

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