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Job Title:  Lead, Quality & Regulatory Compliance Specialist

Req ID:  21669
Job Category:  Quality
Country/Region:  US
State:  TX
City:  El Paso
Zip:  79936
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 Quality Operations is to maintain repeatable and sustainable processes to ensure on-going compliance with domestic and international regulations and standards. This includes championing efficient and effective processes to ensure adherence to all quality system regulations applicable to facility services.

 

The Lead QS & RC Specialist is directly responsible for execution of the quality system. The Lead is also responsible for managing their direct reports serving in the QS/RC Analyst and/or QS/RC Technician positions.  
 

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 and bonus plans
  • Business travel and all related expenses paid
  • 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
  • Establish objectives, mentor direct reports and manage resources to ensure successful execution of the QMS (quality management system).  
  • Direct, coordinate and support activities of the QMS.  
    • Support the implementation and maintenance of quality systems, including data analysis to identify opportunities for quality system improvement.  
    • Maintain independence and oversight for product review and approval.
    • Review and approve protocols and final reports; escalate deviations from performance standards to management.  
    • Monitor and manage site CAPA’s, non-conformances, and Customer complaints.  
    • Write and review quality system work instructions.  
    • Monitor document control, change control and local supplier activities
    • Maintain and execute monthly quality metrics reporting. 
  • Self-monitor your site’s QMS. Conduct internal audits at sister facilities, to ensure the QMS is meeting regulations and standards.  Perform quality system audits and related tasks including pre-planning, execution and report writing.
  • Host/support regulatory, notified body and Customer inspections, including back office support. 
  • Conduct and/or support audit finding investigations. This may include mitigation, corrective action(s) and preventive action(s) where applicable. Collaborate with department managers to develop and implement sustainable remediation action plans.  
  • Continuous Improvement:
  • Lead continuous improvement projects, participate in assigned facility projects, participate as site representative on global projects, and implement global processes (i.e. global work instructions) and other harmonization processes at the site.
     
What You Need To Be Successful
  • Bachelor’s Degree and 4+ years of professional experience required.
  • 3+ years’ experience, preferably including regulatory affairs, legal or governmental compliance, quality systems, internal auditing, applicable scientific, technical or clinical functions and/or healthcare industry experience.
  • Must be able to effectively read, write, and verbally communicate in English. Bilingual (English/Spanish) is a plus.
  • Excellent written and verbal communication skills.
  • Skilled in adapting to changing responsibilities.
  • Ability to work independently under minimal guidelines and supervision
  • Working knowledge of applicable regulations and standards, including, but not limited to, U.S. FDA device QSR, GMP and CGTP regulations, ISO 13485 medical device standard, and ISO 17025 laboratory standard
  • Ability to motivate, train and develop staff.
  • Demonstrated analytical, organizational, and problem-solving skills.

#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.


Nearest Major Market: El Paso

Job Segment: Medical, Quality Manager, CAPA, Quality, Healthcare, Management, Customer Service