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Job Title:  Regional Manager, QS & RC

Req ID:  23840
Job Category:  Quality

South Plainfield, NJ, US, 07080

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

At STERIS the Regional Manager Quality Systems and Regulatory Compliance 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. This position will be based in South Plainfield, NJ but will also support our facility in Northborough, MA. Ability to travel is required.

Duties

Functional Responsibilities: 

  • 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. 
  • 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 principle 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

  • 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.
     

Skills

  • Ability to effectively read, write and verbally communicate. 
  • Ability to travel regionally.
  • 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.   

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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.

Req ID:  23840
Job Category:  Quality

South Plainfield, NJ, US, 07080


Nearest Major Market: New York City
Nearest Secondary Market: Newark

Job Segment: Medical, Regional Manager, Manager, Healthcare, Quality, Management, Customer Service