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Job Title:  Quality Systems & Regulatory Compliance Technician I

Req ID:  25072
Job Category:  Quality

San Diego, CA, US, 92154

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

Join a company where the work you do makes a difference!  We are One Team with One Goal.  At STERIS Applied Sterilization Technologies (AST), it’s our philosophy and our way of doing business.  Through a network of over 50 facilities globally, STERIS AST has been committed to providing contract sterilization services to the medical device, pharmaceutical, consumer, and industrial communities for over 40 years.  Our sterilization services ensure the safety of those who use these products, including our families, our friends, and ourselves.

If you are looking to join a collaborative and innovative team in an essential industry, apply for our Quality Systems & Regulatory Compliance Technician I position today!

 

This position works a 1st shift (Sunday-Thursday 7:30 am – 4:00 pm) and offers overtime potential based on business needs.  Annual merit bonus and incentive plans are also offered.

 

What you will do with us:

1.    Based on established procedures, is responsible for the review and approval of processing files prior to product processing. The review ensures accurate product codes for numbers, case count, and cycle specifications.

2.    Based on established procedures, is responsible for the review of processing files after product processing, and prior to product release, in order to ensure processing parameters have been met.

3.    Assists with the review of operating logs (spectrophotometer, gamma dose computational software log, pre-conditioning, aeration and maintenance) to ensure timely and accurate record keeping processes.

4.    Based on established procedures, assists with the review and maintenance of calibration records to ensure calibration is performed properly and in a timely manner.

5.    Assists in the establishment of appropriate policies and procedures, as well as revision of same.

6.    Assists with writing deviations and documenting Customer concerns based on established Customer specifications and  QS/RC policies and procedures.

7.    With direction from the QS/RC Manager or Analyst, assists with corrective actions as required by process deviations, procedure deviations, complaints, regulatory audits, Customer audits, and internal audits.

8.    With direction from the QS/RC Manager, prepares the monthly internal assessment report.

9.    Contributes to maintaining a safe and clean working environment by performing routine area housekeeping and reporting any unsafe conditions to facility management.

10.    Exhibits a commitment to the AST shared values of Customer Satisfaction and Continuous Improvement through ensuring defect-free workmanship, assisting others to meet the Customer’s needs, searching for efficient and effective ways to reduce waste, being active and accountable for Customer satisfaction, and satisfying the Customer’s needs with a sense of urgency.

11.    Contributes in a team effort by performing according to the guidelines outlined in the STERIS Code of Business Conduct, the GMP, Lean principles and other directives; supports the directives and decisions of higher level management and performs other duties as assigned.
 

How you will learn your role:

•    Review work instructions along with vital policies and procedures
•    Take part in on-the-job training, overseen by your Hiring Manager
•    Demonstrate ability to meet the requirements of the job

Education Degree

  • Associate's Degree

You will be a great fit if you can:

  • Possess an Associate's degree and a minimum of one (1) year of related experience OR a high school diploma/GED and four (4) years of related experience
  • Be dependable and reliable
  • Be a collaborative team player
  • Be attentive to detail
  • Effectively read, write and verbally communicate in English.
  • Work independently under general guidelines and supervision.
  • Demonstrate computer literacy to include word processing, spreadsheet and software capabilities.
  • Demonstrate effective interpersonal skills as demonstrated through prior experience.
  • Demonstrate above average organizing, analyzing and a minimum of Level 3 math skills (ratios, proportions, basic algebra) to determine organizational Customer and regulatory problems to formulate corrective action plans.
  • Adapt to changing duties and responsibilities.
  • Demonstrate normal hearing range sufficient to hear alarms, bells, horns, etc.

Reasons you'll love working here:

This is an opportunity to join a company that will invest in you for the long-term. STERIS wouldn’t be where it is today without our incredible people, who take true pride in their work. That’s why we share in our success together by rewarding employees for their hard work. We do this by providing competitive base salary plus bonus (as applicable), comprehensive benefits package that includes medical, dental, vision, paid PTO and holidays, 401K with company match.

 

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:  25072
Job Category:  Quality

San Diego, CA, US, 92154


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