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Job Title:  Lead, Quality & Regulatory Compliance Specialist

Req ID:  26196
Job Category:  Quality

Libertyville, IL, US, 60048

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 Quality Operations is to maintain repeatable and sustainable processes to ensure on-going compliance with domestic and international regulations and standards in alignment with the STERIS Quality Manual.  This includes championing efficient and effective processes to ensure adherence to all quality system regulations applicable to facility services.

Duties

  1. Provides leadership and direction to Technicians and Analysts by coaching, supervising, and monitoring direct reports through ongoing performance feedback.
  2. Prepares and delivers quarterly performance check ins and final performance reviews
  3. Coaches employees on development plans and actively support employee development.
  4. Supports the implementation and maintenance of quality systems, including data analysis to identify opportunities for quality system improvement. 
  5. Maintain independence and oversight for product review and approval.
  6. Reviews and approves protocols and final reports; escalate deviations from performance standards to their management. 
  7. Monitors and manages site CAPA’s Non-Conformances and Customer complaints. 
  8. Writing and reviewing quality system work instructions. 
  9. Monitors document control, change control and local supplier activities
  10. Maintenance and execution of monthly quality metrics reporting.

Duties - cont'd

11. The Lead, Quality Operations is responsible for self-monitoring of their site’s Quality Management System as well as conducting internal audits at sister facilities to ensure the Quality Management System is meeting regulations and standards.  Perform quality system audits and related tasks including pre-planning, execution and report writing.

12. Host/support regulatory, Notified Body and Customer inspections, including back office support, ensuring requests are met timely and with the highest level of professionalism

13. Responsible for conducting and/or supporting audit finding investigations including but not limited to mitigation, corrective action(s) and preventive action(s) where applicable. Collaborate with department managers to develop and implement sustainable remediation action plans. 

14. Leads continuous improvement projects for facility

15. Actively participates in assigned facility projects

16. Participate as site representative on global projects

17. Implement global processes (i.e. global work instructions) and other harmonization processes at the site

Education Degree

Bachelor's Degree

Required Experience

  1. Minimum of 3 to 5 years professional experience, preferably including regulatory affairs, legal or governmental compliance, quality systems, internal auditing, applicable scientific, technical or clinical functions and/or healthcare industry experience.
  2. Above average organizing, analyzing and a minimum of Level 4 math (practical application of fractions, percentages, ratios, proportions, basic algebra) to determine organizational, Customer and regulatory problems and formulate corrective action plans
  3. Ability to adapt to changing responsibilities
  4. Requires effective interpersonal skills as demonstrated through prior experience
  5. Ability to work independently under minimal guidelines and supervision
  6. 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
  7. Ability to motivate, train and develop staff within their facility
  8. Willingness to demonstrate through daily activities a model of continuous monitoring of quality system activities to ensure compliance to documented standards
  9. Demonstrated ability to analyze data and performance metrics

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers 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:  26196
Job Category:  Quality

Libertyville, IL, US, 60048


Nearest Major Market: Chicago

Job Segment: Medical, CAPA, Medical Device, Quality Manager, Healthcare, Quality, Management