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Title:  European Quality Manager

Req ID:  14275
Category:  Government Affairs
City:  Swindon
State:  UKM
Postal Code:  SN2 8XS
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 by ensuring all Quality Systems/Regulatory Compliance (QS/RC) goals, objectives, strategies and tactics within AST align and promote growth, operational excellence, Customer focus and leadership excellence, and integrate with Customer, regulatory and operational goals.

Has designate responsibility for the Director Quality and Regulatory AST EMEA

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Senior Zone Manager  Quality Systems/Regulatory Compliance (UK/Slovenia/Italy)

Duties

Functional Responsibilities:

  1. Establishes internal audit strategies and procedures to ensure the integrity of AST Quality Systems.
  2. Ensures internal compliance with audit findings and recommendations through the development of a “valueadded perception” throughout operations.
  3. Coordinates the appropriate participation for scheduled and unannounced QS audits by Customers’ standards bodies and regulatory agencies.
  4. Oversees and directs the development and implementation of Dosimetry systems at AST locations, and the designation and acquisition of appropriate analytical equipment, ensuring compliance with all applicable regulations and standards.
  5. Responsible for the integration of multiple quality systems resulting in a succinct, efficient system throughout AST.
  6. Maintains professional skills, knowledge and abilities by attending educational workshops, reviewing professional publications and participating in professional societies.
  7. Provides oversight to ensure that all federal, state and local regulations pertaining to, but not limited to, radioactive materials, licensing compliance, FDA rules and regulations are adhered to. Maintains a working knowledge of applicable regulations and establishes a monitoring program that responds to audit activity in a constructive manner.

Required Experience

  1. A minimum of seven to ten (7-10) years of experience in medical device manufacturing or in sterilization operations, and Quality System FDA regulations and validation is preferred.
  2. 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.

 

 

STERIS plc is a $2B+, publicly traded (NYSE: STE) organization with more than 12,000 employees worldwide.

STERIS strives to be an Equal Opportunity Employer.  

Req ID:  14275
Category:  Government Affairs
City:  Swindon
State:  UKM
Postal Code:  SN2 8XS


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