Danaher Corporation Manufacturing Quality Engineer (Maternity Cover) in O'Callaghan Mills, Ireland
We have an opportunity for a Manufacturing Quality Engineer (Maternity Cover) to join our Quality team based at our facility in Co.Clare.
Co-ordinate the Manufacturing Non-conformance process (NC) for all BCII Production areas ensuring compliance to Quality and Regulatory Standards.
Participate in cross functional teams providing Quality guidance and support in the determination of appropriate NC root cause analysis and implementation of effective corrective actions.
Prepare and co-ordinate the Rework process, ensuring relevant documentation is prepared, reviewed and approved as per company procedures as well as completing Acceptable Quality Level (AQL) inspections prior to product disposition.
Execute the Stop Ship process for finished product released to the market, in the Oracle system, ensuring process is compliant to relevant company procedures.
Provide guidance and support to all departments ensuring Good Manufacturing Practices (GMP) and Quality System Regulations are complied with during the production of product.
Initiate/review/approve document Change Controls (CCFs) and Equipment Change Controls (ECCs) ensuring Good Manufacturing Practices are maintained and comply with company procedures.
Provide Quality expertise during investigations, process FMEAs and daily manufacturing issues driving process improvements as well as acting as the Quality Representative on design change projects, if applicable.
Review/approve Validation documentation (e.g. protocols, reports) ensuring compliance to applicable procedures.
Assist with the QA review & disposition of Batch History Records (BHRs) for all product lines and complete the associated ERP activities ensuring relevant logs and BHRs are maintained.
Participate in the BCII Internal Audit Programme as well as representing Manufacturing Quality in both Internal and External audits.
Perform CAPA (corrective and preventive action) activities and document in the Global CAPA system if required.
Ensure quality issues are communicated to the management team such that they are aware of any potential problems or opportunities. Additionally, generate, analyse and report quality metrics to relevant personnel and to ensure on-going improvement programmes are put in place.
Develop strong, positive and beneficial working relationships and effective information flow with other departments and within the Quality department.
Generate, update, implement and complete associated training for relevant departmental procedures, as required.
Duties as prescribed by the Manufacturing Quality Supervisor.
Education & Experience:
Bachelor’ s degree (Level 8 ) in chemistry, biochemistry, engineering or other relevant technical field with a minimum of 2 years’ experience in a highly regulated (FDA desirable) healthcare or related environment, or
Master’s degree in chemistry, biochemistry, engineering or other relevant technical field with a minimum of 0-2 years’ experience in a highly regulated (FDA desirable) healthcare or related environment.
Desirable to have previous experience in IVDDs and Manufacturing Quality.
Good knowledge of ISO9001/ISO13485, FDA and GMP requirements.
Excellent time management, planning and organisation skills.
Effective interpersonal and verbal/written communication skills.
Strong team member with the ability to identify and drive quality improvements.
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.