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Job Title:  QS & RC Analyst I

Req ID:  20122
Job Category:  Quality
Country/Region:  US
State:  CA
City:  Temecula
Zip:  92590
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.

We are currently looking for a Quality and Regulatory Analyst, to join our team, at our Temecula, CA facility. In this role, you will be responsible for the activities related to Quality Systems/Regulatory Compliance (QS/RC) procedures. You will ensure all product processing requirements are met, in accordance with Customer specifications, including calibrations, generation of test methods, audits, scheduling, validations, record keeping and reporting, as directed by the QS/RC Manager. 

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:
  • Periodically perform pre-review of processing files for new product, or new specification requirements.
  • Perform or facilitate the review of operating logs (spectrophotometer, gamma dose computational software log, pre-conditioning).
  • Perform or facilitate the review and maintenance of calibration records.
  • Establish or facilitate the establishment of appropriate policies and procedures, as well as revisions and maintenance of AST quality systems.
  • Write, or assist in the writing of, deviations and responses to deviations, as well as documenting Customer concerns based on established Customer specifications and QS/RC policies and procedures.
  • Develop corrective actions as required by process deviations, procedure deviations, complaints, regulatory audits, Customer audits and internal audits. Develop training materials, and train employees, in response to procedural changes, policy changes and improvement activities.
  • Prepare or facilitate the preparation of the monthly internal assessment report.
  • Manage and provide deliverables or special projects such as procedure revisions. Develop vehicles and tools and conduct analysis of relevant metrics to identify areas for continuous improvement.
  • Provide support in the forms of data, documentation and feedback for Customer and/or regulatory audits, as well as internal audits.
  • Monitor data and trends relative to the Quality system; make recommendations for improvement and establish implementation plans.
  • Exhibit 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.
  • Contribute 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.
What You Need to be Successful:
  • Bachelor’s Degree and 3+ years of related experience required.
  • 3+ years of experience in Quality, Audit, and Regulatory a must; to include knowledge of, and experience with ISO 13485 regulations. Experience with FDA 21 CFR Part 820/211 a plus.
  • Must be able to effectively read, write and verbally communicate in English. Bilingual (Spanish/English) a plus.
  • Ability to work flexible hours (at times outside “normal business hours”) and travel as required. Standard hours for this role are Monday-Friday, 7:30 am – 4:00 pm.
  • Comfortable working independently, with or without supervision.
  • Effective interpersonal skills as demonstrated through prior experience.
  • Computer skills to include Microsoft Office programs and successfully navigating a computer.
  • Strong attention to detail, along with technical, organizational, problem-solving and troubleshooting skills.
  • Flexibility to handle multiple, changing priorities.
  • Ability to influence others, and to make decisions in stressful situations.

#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.