Share this Job

Job Title:  Quality Systems & Regulatory Compliance Analyst II

Req ID:  17490
Job Category:  Regulatory Affairs
Country:  US
State:  CA
City:  San Diego
Zip:  92126
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.

Header

Monday thru Friday while in training,

Then Sunday thru Thursday 7 AM to 3:30 PM

Position Summary

Provides senior level expertise for all activities related to Quality Systems/Regulatory Compliance (QS/RC) procedures to ensure all product processing requirements are met in accordance with Customer specifications.  Provides guidance and direction to QS/RC Analysts, and recommends and initiates quality improvements.  Acts as the facility representative and primary quality system contact as needed or assigned.

Duties
  • Develops and administers the facility’s products, processes and quality systems, and acts as designated signatory when assigned by facility or regional QS/RC Manager.
  • Ensures that processing files are reviewed for compliance for new product or new specification requirements after product processing and prior to product release in order to ensure processing parameters have been met.
  • Provides direction and assistance during Customer audits of the facility, serving as the primary escort, and provides support in the forms of data, documentation and feedback for Customer and/or regulatory audits, as well as internal audits.
  • Reviews and recommends approval for protocols and final reports generated through the EO or Gamma Tech Center for sterilization process validation.
  • Ensures process control through review of operations records, maintenance programs and other record keeping requirements.  Reviews and recommends for approval Engineering Change Orders.
  • Administers the facility Corrective and Preventive Action system including overseeing or developing corrective actions as required by process deviations, procedure deviations, complaints, regulatory audits, Customer audits and internal audits, and develops training materials and trains employees in response to procedural changes, policy changes and improvement activities.
  • Establishes or facilitates the establishment of appropriate policies and procedures as well as revision and maintenance of the Quality Systems/Regulatory Compliance (QS/RC) Policy and Procedure Manual.
  • Prepares or facilitates the preparation of the monthly internal assessment report
Duties - cont'd
  • Manages and provides deliverables or special projects such as procedure revisions. Develops vehicles and tools, and conducts analysis of relevant metrics to identify areas for continuous improvement.
  • Provides support in the forms of data, documentation and feedback for Customer and/or regulatory audits, as well as internal audits.
  • Monitors data and trends relative to the Quality system and makes recommendations for improvement as well as establishes implementation plans.
  • Maintains professional skills, knowledge and abilities by attending educational workshops, reviewing professional publications and participating in professional societies
  • Ensures that FDA rules and regulations are adhered to.  Maintains a working knowledge of regulations and establishes a monitoring program that responds to audit activity in a constructive manner.
  • Communicates in an effective manner by utilizing accepted business practices in a courteous and professional manner providing timely and accurate responses and service oriented offers of assistance.
  • Protects company confidential information by properly storing, retrieving and disseminating such information only to those authorized.
  • 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.
  • 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.
Education Degree
  • Bachelor's Degree
Required Experience
  1. Requires a minimum of three to five (3-5) years of related experience plus two (2) years direct experience with administrative and Quality systems.
  2. Previous sterilization process experience or related training preferred.
  3. Requires ability to effectively read, write and verbally communicate in English.
  4. Requires ability to work independently under general guidelines and supervision.
  5. Requires effective interpersonal skills as demonstrated through prior experience.
  6. Computer skills and work processing, spreadsheet and software capabilities.
  7. Requires above average organizing, analyzing and Level 4 math skills (practical application of fractions, percentages, ratios, proportions, measurements and basic algebra) to determine organizational Customer and regulatory problems and formulate corrective action plans; attention to detail.
  8. Able to adapt to changing duties and responsibilities.
  9. Able to influence people in the opinions, attitude or judgments; to generalize, evaluate and decide; to adapt to situations under stress.
  10. Requires normal hearing range sufficient to hear alarms, bells, horns, etc; normal visual acuity.

 

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: San Diego

Job Segment: Medical, Systems Analyst, Engineer, Inspector, Healthcare, Technology, Quality, Engineering