- Reference: GY45106AO
- Job Type: Permanent
- Location: Galway, Limerick
- Category: Engineering, Technical & Manufacturing
Duties and responsibilities include:
- Provide quality engineering support to designated areas.
- Coordinates and perform Supplier Audits and Internal Quality Audits and inspections as required.
- Promote Good Manufacturing practices and ensure others adhere to the quality system requirements.
- Contribute to continuous improvement of systems and practices
- Review company systems and procedures to ensure effectiveness;
- Participate in CAPA, Complaint Handling and MRB meetings
- Provide support for Complaint handling activities across multiple facilities in Europe.
- Preparation of monthly KPI metrics for review by the Quality Assurance Manager.
- Auditee for Corporate/Regulatory body/Customer audits
- Ensures compliance with all applicable domestic and international regulatory requirements and quality system regulations and standards.
Qualifications and skills required:
- Bachelor’s degree from four-year college or university in an engineering or scientific discipline (Electronics, Mechanical or Chemistry Sciences, Physics or related) or two to four years related experience and/or training; or equivalent combination of education and experience.
- Possess a good working knowledge of regulatory expectations and industry practices including industry standards QSR, ISO13485, MDD, CMDR, JPAL.
- Excellent organizational; problem solving; decision making; communication (oral and written); and influencing skills.IT/Engineering Cert or equivalent.
- Work experiences in a medical device company are advantageous
For a confidential discussion and more information on the role/company please email your CV to: firstname.lastname@example.org
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