Job Title

Quality Engineer

Job Descriptions

Job Title: Quality Engineer
Department: Quality
Reports To: Quality Manager, Ireland

SUMMARY

Meissner has an exciting opportunity for an experienced Quality Engineer to join the team. 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 Quality Manager.

Essential Duties and Responsibilities

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

General

 Work with Quality Department in HQ to sustain, monitor, and continuously improve the
established 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

 Assist in managing Meissner SOPs and Document Control.
 Assist in managing 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 the oversight of training compliance to Meissner SOPs.

QC/QA

 Interface with Meissner’s 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, issues 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 sterilisation suppliers.

Sterilization Supplier Management

 Act as primary contact for Meissner Castlebar on all aspects of sterilization supplier
management.
 Identify, evaluate and qualify gamma and X‑ray contract sterilization providers.
 Conduct on‑site audits of sterilization providers.
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 to
successfully function in this position. 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 with contract radiation sterilization (gamma and/or X‑ray) and sterilization
validation activities.
 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.

Physical Demands

Occasional work may be done in an ISO Class 7 cleanroom environment. Powder free gloves, face
masks, hairnets, gowns, and shoe covers must be worn. Because 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 enter or work in the cleanroom. As a result, the
successful candidate must be a nonsmoker.
Meissner Filtration Products is Proud to be an Equal Opportunity Employer.

Qualifications

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Skills

Experience

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