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Quality Engineer

Quality Engineer

Quality Engineer

Job Category

Engineering

Job Industry

Manufacturing

Job Location

Castlebar, Connacht

Date Opened

2021-11-16

Job Description


JWR Employment Specialists are delighted to be working with a growing international manufacturing company located in Castlebar to recruit anexperienced Quality Engineer.


This is a critical quality position associated with the operation of a new manufacturing facility located in Castlebar, Co. Mayo.  The Quality Engineer will report directly into the Quality team based at our client’s corporate headquarters in California, U.S.A. with local reporting and support onsite by the Director of Operations – Castlebar.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

These include the following; others may be assigned to meet business needs.

 

General:

  • Work with Quality Department in HQ to become familiar and implement all aspects of the QMS at the Castlebar facility.
  • Communicate regularly with Quality at HQ to ensure consistent adherence to the company’s QA program.
  • Use ‘Front’ software proficiently to become an integral part of Quality group.
  • Support and perform measuring, testing, and tabulating data concerning quality and reliability.
  • Manage customer related communication in regards customer queries, deviations and issues.

Document Control:

  • Site lead for managing SOPs and Document Control.
  • Manage quality training programs at Castlebar site to ensure these effectively mirror what is in place at HQ.

Training:

  • Provide quality related training for new employees with respect to quality orientation.
  • Site lead for training compliance to SOPs

QC/QA:

  • Interface with MRP/MES systems to control QC/QA functions thereof.
  • Work with production team to be familiar with production processes, component and finished goods quality attributes, manufacturing records, acceptance and release criteria of the products to ensure compliance with contract and regulatory specifications.
  • Assist in supervision and/or performing incoming QC on incoming raw materials.
  • Assist the final release for products manufactured in Castlebar.
  • Assist with any quality investigations arising from operations at the Castlebar facility.
  • Ensure that the quality of all product leaving the facility meets predetermined standards commensurate with that manufactured at our HQ facility.

Supplier Management:

  • Interface with purchasing department on new material and new supplier onboarding activities.
  • Manage and maintain supplier related documentation, issue and metrics related to the Castlebar site.
  • Support the completion of supplier documentation surveys and questionnaires.
  • Lead / Support supplier quality audits of external vendors.
  • Manage compliance and relationship with GAMMA sterilisation supplier.

 

Validation, Qualification, Calibration and Routine Surveillance:

  • Assist with the ongoing certification of the cleanroom manufacturing environments and associated controlled areas.
  • Review monthly QBMS compliance reports to ensure compliance.
  • Track and trend Quality related programs and KPIs in coordination with HQ.
  • Participate in the validation and verification of new equipment and processes.
  • Oversee lifecycle of validated and qualified equipment, utilities and processes at the Castlebar site.
  • Manage and maintain compliance to Calibration procedure on site.

 

Client Support

  • Support customer audits and site visits.
  • Support pre and post audit activities.
  • Assist in completion of customer documents and questionnaires.

 

ABOUT THE COMPANY

This company has been serving the critical needs of their client base since 1984. They have pioneered filtration technologies for the pharmaceutical and biopharmaceutical marketplace and have been instrumental in developing the standards which govern sterile filtration today. In the early 2000s, they expanded our product offering into the emerging single-use systems market by building our capacity from the ground up. Today, single-use systems, which are used in the manufacture of cutting edge and lifesaving medicines, are the fastest growing part of the business, and these are the products manufactured at the facility.


They are the largest privately held filter and single-use systems manufacturer in the world, and the fastest growing company in both of these market segments. They are fiercely independent as this best serves the needs of our customers. They relish the competitive advantages being a privately held company provides, including the ability to move quicker and execute without the need to answer to public shareholders.


Requirements

The Quality Engineer is a key position at the facility in Castlebar. It is critical that the quality of the products produced there meet the standards of those produced in California, and this position will be fundamental in accomplishing as much. Excellent organisational and communication skills are required to effectively fill this role.


The requirements listed below are representative of the knowledge, skill, and/or ability required to successfully function in this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Education and/or Experience

  • Educated to a Minimum Level 8 in an Engineering, Science or Quality Assurance discipline
  • 5+ years’ experience in an industry related quality role.
  • Experience with cleanroom-based operations, GMP regulations, Production and/or Pharmaceutical industry experience is desired.
  • Experience working in a highly regulated industry is very beneficial.
  • Demonstrated critical and effective decision-making skills with the ability to work on one’s own initiative to resolve competing priorities and with minimum supervision is required.
  • Must be proficient with MS Office software including Outlook, Word, and Excel.
  • Must possess excellent verbal & written communication skills, which include but are not limited to presentation and organizational skills
  • Ability to read and interpret documents in English such as SOPs, safety rules and quality guidelines.
  • Excellent Attention to detail.
  • Coordinate with other departments to ensure cohesive actions that involve quality control expertise or interaction.
  • Be a strong team member with the ability to identify and drive quality improvements.
  • Ability to organize and judge priorities and work independently with minimal supervision.
  • Supplier Auditing experience and/or Lead auditor qualification is an advantage. 

 

TRAVEL

As noted herein, some time, surmised to be on the order of one (1) month will be spent at HQ. The Quality Engineer will be tasked with ensuring consistent communication with the Quality team based at HQ to ensure that the quality of products leaving our Castlebar facility are equivalent with those produced in California.

 

OTHER CONSIDERATIONS

As smokers continue to shed thousands of smoke particles even hours after smoking a cigarette and these particles will damage our products, only non-smokers are permitted to work in the facility.

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