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Job Title:  QS & RC Specialist

Req ID:  24096
Job Category:  Regulatory Affairs

Mentor, OH, US, 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.

Overview

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. 

What We Offer You

This is a great opportunity to join a well-established, global company that will invest in your career growth over the long term. STERIS wouldn’t be where it is today without our incredible, talented 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 offer a comprehensive benefits package, including:

  • Competitive pay
  • Annual merit bonus and incentive plans
  • Business travel and all related expenses paid
  • Training and coaching
  • Medical, vision, dental and life insurance
  • 401(k) with a company match
  • Paid vacation time and paid holidays
  • Tuition assistance
  • Opportunities for advancement

 

What You Will Do

Product Corrections and Removals

  • Assemble product and Customer data concerning product corrections and removals, tracking of Customer notifications and Field Service repairs, and maintenance of correction documentation.


Medical Device Reporting

  • Investigate complaints for potential reporting under the FDA Medical Device Reporting regulations, prepare draft complaint summaries and MDR/Vigilance reports for presentation to the Reportable Events Committee for review, and maintaining documentation in accordance with department policies, procedures, and work instructions.  

 

Quality Audits

  • Provide support to Quality & Regulatory Compliance management 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.  

 

Observation Follow-up

  • Provide support to the Quality & Regulatory Compliance team in the investigation and resolution of global CAPAs.
  • At the direction of Quality and Regulatory Compliance management, 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.

 

What You Need To Be Successful

  • Bachelor's Degree required. Science, Engineering, Regulatory, Internal Audit, or Business degree concentration preferred.
  • Ability to travel as required. Travel is estimated at 10%.
  • No prior experience required. Internship experience within a regulatory, compliance or quality function is preferred.
  • Effective time management, organizational and problem solving skills required.
  • Strong interpersonal skills – ability to work closely with people at all levels within the organization and facilitate the implementation of corrective actions; ability to work effectively and professionally with individuals outside the organization including Customers and government officials. 
  • Excellent PC skills, including Microsoft Office applications
  • Experience working on cross-functional teams; able to lead cross-functional team when required.
  • Strong oral and written communication skills.
  • Ability to balance multiple high priority responsibilities on-time and effectively. 
  • Demonstrate through your daily activities a model of continuous monitoring of our quality system activities to ensure compliance to documented standards.

#LI-KW1

 

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.

Req ID:  24096
Job Category:  Regulatory Affairs

Mentor, OH, US, 44060


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

Job Segment: Medical, Engineer, Intern, Inspector, Medical Device, Healthcare, Engineering, Entry Level, Quality