Quality Engineer
at Mason Alexander
Wexford, County Wexford, Ireland -
| Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
|---|---|---|---|---|---|---|---|
| Immediate | 21 Jul, 2024 | Not Specified | 28 Apr, 2024 | 2 year(s) or above | Minitab,Qsr,International Regulations,Microsoft Office,Ul | No | No |
Required Visa Status:
| Citizen | GC |
| US Citizen | Student Visa |
| H1B | CPT |
| OPT | H4 Spouse of H1B |
| GC Green Card |
Employment Type:
| Full Time | Part Time |
| Permanent | Independent - 1099 |
| Contract – W2 | C2H Independent |
| C2H W2 | Contract – Corp 2 Corp |
| Contract to Hire – Corp 2 Corp |
Description:
Responsibilities:
- Adheres to all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
- Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
- Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
- Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
- Lead generation and completion of protocols and reports for test method validations.
- Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
- Develops various inspection techniques and procedures to ensure product integrity to design specifications.
- Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
- Ensure that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
- Lead and manage complaint investigations.
- Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
- Participate in continuous improvement projects.
- Assist with product transfers.
- Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, assists each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing
REQUIREMENT SUMMARY
Min:2.0Max:5.0 year(s)
Pharmaceuticals
Production / Maintenance / Quality
Clinical Pharmacy
Graduate
Engineering or related field required
Proficient
1
Wexford, County Wexford, Ireland
