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Job Title:  Regulatory Affairs/Quality Compliance Manager

Req ID:  17014
Job Category:  Quality
Country/Region:  US
State:  CA
City:  San Diego
Zip:  92126

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 success of STERIS and our Customers is powered by our people, a culture of teamwork, and continually improving the effectiveness of our Quality System as a foundation for business performance. We value safety, integrity and mutual respect.  
We are looking for a motivated, reliable and experienced Quality Systems and Regulatory Compliance Manager to join our team!  This role will be responsible for establishing a culture of quality and ensuring sustainable quality of our processes, internal policies, procedures and services before Customers' use. 

What You Will Do

Oversee internal processes and procedures to ensure quality
Manage a staff of direct reports to include performance management, training, and hiring.
Responsible for leading Customer, Regulatory and Registrar on-site audits
Regularly analyze quality data and suggest actions based on collected data
Manage the log of quality reports and other quality documentation
Ensure quality and sustainability of production processes
Investigate customers' needs and develop a strategy for meeting their needs
Communicate with the Production team on a daily basis

What You Need To Be Successful

Bachelor’s in Science, Engineering or related field
Minimum of 6 years of experience as a Quality Assurance Manager or similar role
Knowledge and understanding of the industry’s regulations and best practices
Hands-on experience with a variety of reporting operations and procedures 
Good organizational and time-management skills including the ability to multi-task
Strong interpersonal and communication skills
Critical-thinker and problem-solver
Numerical skills and understanding of data analysis/statistical methods
Knowledge of MS Office and databases

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 $2B+, 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.