Quality Engineer
Department:303-Quality
Location:Castlebar, Mayo, 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.
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.
- Work with the Quality Coordinator to ensure incoming QC of incoming raw materials performed effectively.
- 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 sterilization 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.
Customer Support
- Support customer audits and site visits.
- Support pre and post audit activities.
- Assist in completion of customer documents and questionnaires.
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.
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.
