Quality Engineer – Mayo

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

This is a critical quality position associated with the operation of our manufacturing facility located in Castlebar, Ireland. The role will be responsible for supporting the Quality Department in the implementation of all aspects of the QMS, while also engaging with their counterparts in Camarillo to ensure the transfer of best practices between the two sites. The Quality Engineer will report locally to the Senior Quality Engineer.

Duties and Responsibilities:

Duties and responsibilities include the following. Other duties may be assigned.

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:

• Support the management of 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.
• Support 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.
• 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.

Qualifications, Education & Experience:

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

• 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.