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Job Title:  Site Quality Manager

Req ID:  15830
Job Category:  Quality
Country:  IE
State:  MO
City:  Westport
Zip:  F28 AF54
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

Plans and maintains quality assurance systems to ensure process and test reliability and conformance to Steris Customer and regulatory requirements. As a member of the site Management team, contributes to performance of the Company and provides inputs and suggestions on normal routine business matters.

 

In conjunction with the Ireland (Country) QA Manager, responsible for Quality Assurance and Technical matters relating to the Gamma facility (Westport).

Duties

  1. The Site Quality Manager has specific and general responsibilities in respect to the Quality System.
  1. Is the Designate Management Representative with the authority and responsibility to ensure the

documented Quality System is implemented.

  1. Audits, generates reports and quality plans and verifies that the necessary corrective actions are taken to ensure ongoing compliance with the Quality Manual.

 

Has specific authority and responsibility to:

  1. Initiate action to prevent the occurrence of a process non-conformity.
  2. Identify and record any process quality problems.
  3. Initiate, recommend or provide solutions to quality problems through designated channels.
  4. Verify the implementation of solutions.
  5. Control further processing, delivery or release of Customer product pending completion of corrective

action on nonconforming product.

 

  1. Responsible for ensuring appropriate systems for release of client product post processing.
  2. Analyses Customer complaints and implements corrective actions for valid complaints.
  3. Responsible for Document Control function.
  4. Responsible for facilitating Customer and Regulatory audits including generation of corrective actions

And ensuring responses to the relevant third party. Ensuring the promotion of awareness of

Regulatory and Customer requirements throughout the organisation.

Duties - cont'd

Responsible for ensuring process commissioning, validation and any subsequent re-validation deemed

necessary as a result facility engineering changes or customer product/requirements changes are

Documented, approved and implemented

 

  1. Provides technical assistance and support to Customers in the development of validation

protocols subsequent validation reports, and routine processing problems.

  1. Responsible for ensuring process, test and raw materials specifications remain current, by conduction

Internal audits, ensures that these specifications are met.

 

9.    To ensure compliance with safety procedures at all times.

10.  Provides support to ongoing continuous improvement efforts and LEAN activities within Steris.

 

Education Degree

Vocational/Technical in Science

Bachelor's Degree in Science

Required Experience

3-5 years relevant industrial experience with Quality  systems.

 

Requires comprehensive knowledge and hands-on experience of quality standards and procedures;

ideally in the area of sterilisation and validation.

 

Working knowledge and experience of medical device manufacturing, related GMP and an appreciation of FDA compliance inspections.

 

Ability to work well with people and act as a facilitator to STERIS staff not directly reporting to this position is important.

 

Ability to communicate with clients is essential.

#LI-SS1

 

 

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.  


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