Job Description
Our client, a medical devices manufacturer based in Galway, now seeks a suitable and experienced Senior Quality Engineer.
The successful candidate will plan and execute product/process development activities and transfer such processes into the manufacturing environment.
This is a permanent role based in Galway.
Responsibilities of Senior Quality Engineer:
- Lead and manage quality support to assigned production departments ensuring product manufactured conforms to quality standards and specifications, GMPs of all medical device regulatory agencies (eg. FDA, ISO and MDD).
- Determining inspection frequencies and sampling plans using significant testing and capability studies; Implementation of Statistical Process Control in areas where needed and appropriate, analysis of data obtained.
- Monitor and evaluate quality inspection procedures to ensure consistency, compliance and effectiveness, making recommendations for improvement and/or adjustment where needed to Technical Teams / Management for assigned Production Departments (Component, Sub Assembly & Finished Goods). Where appropriate implement approved changes.
- Review and assessment of all quality records (batch documentation, calibration, incoming quality inspection, finished goods quality inspection) relating to assigned production areas as appropriate.
- Non-conforming product review and disposition; investigation of deviations/returned goods and implementation of appropriate and effective corrective / preventive actions to improve product quality and output.
- Providing guidance, direction to product line Quality Assurance Auditors, Quality Technical & Engineering Staff, Lead operators / Supervisors on quality aspects of products relating to production departments assigned.
- Provide Quality Performance Information to members of Senior Management, (Tech Team Updates / as deemed necessary) - Quality representative on relevant Technical Team(s).
- Review of document change orders to evaluate each change for quality related issues, initial product release documentation review.
- Completion of retrospective validation, prospective validation or revalidation of products / processes / tooling or methods as necessary.
- Performance of Internal Quality Audits.
- Quality System improvement identification and implementation.
- Supervises Technical Staff and Quality Auditors and deputise for Manager, Quality Assurance, as required.
Requirements of Senior Quality Engineer:
- Bachelor?s Degree in Engineering or equivalent technical qualification; postgraduate in Quality Management
- Six (+) years? experience in Quality environment, preferably in Healthcare/Medical Device industry.
- Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), ISO 13485 Quality System Standard, ISO 14971 Risk Management, Canadian Medical Device Regulation (CMDR), and JPAL/JGMP.
- Experience of applying Lean Six Sigma techniques to improve business processes & performance required.
- PC skills including standard offices packages as well as ability to understand and learn customised computer software programs
For more information and in strict confidence please send an up to date CV and cover note to John Reid at the RFT Group johnr@rftgroup.ie/ 01-2302400 / www.rftgroup.ie
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.