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Danaher Corporation Senior Manufacturing Quality Engineer (18month FTC) in O'Callaghan Mills, Ireland

Beckman Coulter, currently have an opportunity for a Senior Manufacturing Quality Engineer to join our QA Team based at our Co.Clare facility. This role has responsibility to support the quality activities associated with the establishment of a manufacturing facility to produce Blood Virus (BV assays)

Typical responsibilities will include but are not limited to the following:

  • Provide strong leadership and support in the Manufacturing Quality processes/documentation.

  • Review and approve New Product Development Process Validation documentation/deliverables ensuring compliance to applicable procedures.

  • Lead the Non-conformance processes (NCs) for New Product Development areas ensuring compliance to Quality and Regulatory Standards.

  • Creation, review and approval of Equipment and Manufacturing documentation. Initiate/review/approve document Change Controls (CCFs) and Equipment Change Controls (ECCs) ensuring Good Manufacturing Practices are maintained and comply with company procedures to support Project Deliverables.

  • Ensure Quality project deliverables are achieved within agreed timelines and in compliance with global and local procedures/work instructions.

  • Provide Quality expertise during investigations, process FMEAs and daily manufacturing issues driving process improvements.

  • Lead/participate in cross functional teams providing Quality guidance and support to all departments ensuring Good Manufacturing Practices (GMP) and Quality System Regulations are complied with during the receipt/production of product.

  • Analyse and report meaningful quality metrics to ensure on-going improvement programmes are put in place and continually strive for customer satisfaction.

  • Ensuring that internal or external quality issues are effectively prioritised and acted upon in a timely manner, particularly those in the NC/SCAR process.

  • Perform CAPA (corrective and preventive action) activities and document in the Global CAPA system (Smartsolve) if required.

  • Develop strong, positive and beneficial working relationships and effective information flow with other departments and within the Project team and Quality department.

  • Ensure area procedures as well as operational area procedures are updated to ensure compliance. Generate, update, implement and complete associated training for relevant departmental procedures, as required.

  • Represent Quality at both internal and external audits.

  • Conduct internal audits to ensure compliance to the QMS.

  • Use of Danaher Business System (DBS) tools and techniques to streamline start up processes and ongoing Quality operations e.g. Standard Work, Transactional Processes, kaizen planning event and lead the implementation of new technologies and innovative solutions into quality activities as appropriate.

  • Duties as prescribed by the Quality Lead and/or Operations Quality Manager.

Education/ Experience:

  • Bachelor’s Degree(Hons Level 8) in field with 5+ years exp. OR Master’s degree in field with 3+ years exp.

  • Strong knowledge of ISO9001/ISO13485, FDA and GMP requirements.

  • Desirable to have previous experience in Manufacturing Quality, manufacture of Immunoassays and/or Process/Equipment validations.

  • Strong team member and ability to identify and drive quality improvements

  • Excellent time management and organisation skills.

  • Effective interpersonal and verbal/written communication skills.

  • Strong proof reading skills with emphasis on attention to detail.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.

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