Senior Quality Engineering opportunity with an SME Med-Device company in Galway
I am currently working with an SME Medical Device company who are based in Galway. This company is involved in Class I, II, III medical device development and manufacturing solutions. They are certified to ISO 13485:2016 and are looking for a Senior Quality Engineer to join the team. This role will be reporting into the Quality Manager.
While this will be a heavily Quality focused role it will encompass some validation elements so there will be some requirement for validation (product/process/test method validation)
The key elements to this role are:
- Quality support to assigned product development teams ensuring product manufactured conforms to quality standards, specifications, customer expectations, and associated regulations, e.g. FDA, ISO and MDD
- Provision of functional input into risk management processes such as FMEA development, etc
- Assistance with site to site manufacturing transfers
- Review and verification of quality records (batch documentation, calibration, incoming quality inspection, finished goods quality inspection) relating to assigned production areas
- Provides guidance on equipment calibration procedures as relevant
- Provides guidance on inspection & test methods and associated sampling plans, etc
- Non-conforming product review and disposition, associated investigation and root cause analysis, and implementation of appropriate and effective corrective actions
- Initiation, review and approval of document change controls
- Performance of internal audits of the QMS. Provide guidance and support on audit outcomes as relevant
- Performance of supplier audits and associated supplier management including supplier corrective action responses, etc
- Some travel required
- Bachelors degree in Science/Engineering - related discipline or equivalent
- 5+ years relevant experience working in medical device-related quality function
- QMS Auditor Certification desirable
Working Knowledge of:
- FDA 21CFR, ISO 13485, ISO 14971, MDD, etc
- Internal & Supplier Auditing
- External Audit facilitation such as NSAI, FDA, etc
- Mentoring and Training Individuals
- Software Validation & Calibration
- LEAN Manufacturing or comparable continuous improvement systems
- Six Sigma Process Improvement Methodologies
If this sounds like you, or if you would like to discuss other Quality Opportunities in Galway or further afield, click on the 'Apply Now' button below and I can call you for a confidential discussion. Or get in touch on 021 2300 300.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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