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Job Title:  Senior Manager, Quality Systems

Req ID:  25740
Job Category:  Regulatory Affairs

Ontario, CA, US, 91761

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

Provides leadership and direction at the facility level, regionally and throughout the AST organization in ensuring that Quality Systems &Regulatory Compliance (QS/RC) goals, objectives and activities align with Customer and regulatory goals, as well as operational goals.

Duties

DUTIES
•    Performs all functions and responsibilities of a facility Quality Systems/Regulatory Compliance (QS/RC) Manager. 
•    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. 
•    Operational Responsibilities: 
•    Provides leadership and direction in ensuring that QS/RC activities within the region are consistent with 
•    QS/RC goals, objectives, strategies and tactics. This is accomplished through the ongoing and 
•    systematic identification of opportunities for improvement and ensuring that corrective and preventive 
•    actions required as a result of internal, Customer and regulatory audits, non-conformance, system 
•    deviations and Customer complaints are responded to in a manner which meets requirements and 
•    business objectives. 
•    Manages, monitors and mentors the regions QS/RC Managers through ongoing performance feedback 
•    and formal reviews, as well as development initiatives which target individual strengths and weaknesses 
•    while delivering business results. 
•    Assists the Director of QS/RC in developing an AST strategy that integrates the QS/RC function, its 
•    processes, as well as the managers as partners with operations. 
•    Assists with the establishment and adheres to a QS/RC budget as well as monitoring that budget through 
•    the establishment of controls and review of expenditures. 
•    Assists the Director of QS/RC in the preparation of periodic management reviews and ensures 
•    appropriate follow up on all recommended corrective action(s). 
•    Informs the Director of QS/RC of scheduled and unannounced QS audits by Customers, standards 
•    bodies and regulatory agencies through updates regarding potential regulatory or standards body 
•    identified non-compliance or risks, discussion and review of audit responses and resulting follow through.
•    Supports a safe, clean and secure working environment by supporting procedures, rules and regulations; 
•    supports plant safety committees that evaluate plant machinery, equipment and working conditions. 

Duties - cont'd

•    Promotes and protects the company reputation by participating and representing the company in local 
•    community activities. 
•    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

•    Bachelor’s Degree of Arts or Science degree in microbiology or related science, or the equivalent in 
education and experience preferred.
•    Professional Certification- Preference is given for ASQ certification
•    A minimum of five to seven (5-7) years of experience in medical device manufacturing or in sterilization 
operations, and Quality System FDA regulations and validation is preferred. 
•     ISO 9000 and ISO 13485 standard and AAMI industrial sterilization methods experience preferred and 
experience with statistical technique such as SPC and experimental design experience preferred.
 

Preferred Experience

•    Ability to effectively read, write and verbally communicate. 
•    Ability to work independently under general guidelines and supervision. 
•    Computer skills and work processing, spreadsheet ad software capabilities. 
•    Effective interpersonal skills as demonstrated through prior management experience 
•    Above average organizing, analyzing and Level 4 math skills (advanced algebra and/or calculus and/or 
•    statistics) to determine organizational Customer and regulatory problems and formulate corrective action plans; 
•    attention to detail. 
•    Ability to adapt to changing duties and responsibilities. 
•    Ability to influence people in the opinions, attitude or judgments, to generalize, evaluates and decides, to adapt 
to situations under stress. 
•    Normal hearing range sufficient to hear alarms, bells, horns, etc.

Skills

 

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.

STERIS strives to be an Equal Opportunity Employer.  

Req ID:  25740
Job Category:  Regulatory Affairs

Ontario, CA, US, 91761


Nearest Major Market: Riverside
Nearest Secondary Market: Los Angeles

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