Our Client a major multinational based here in Galway are looking for a Quality Engineer for an exciting new project on a fixed-term contract.
The Quality Engineer is a member of the Quality department and plays a key role in ensuring that the Quality System functions are maintained in compliance with documented procedures. The Quality Engineer supports the IDEM (Infectious Diseases Emerging Market) Business Unit’s QMS integration activity across the site to ensure on-going compliance and continuous improvement. The Quality Engineer works on various activities such as non-conformance investigations, internal / supplier audits, complaint activities, process improvements etc which support and guide the IDEM sites in discharging their regulatory.
Overview of Main Responsibilities (full job description available on request):
- Support Global Business Unit (BU) in executing on global supply issues including communicating with suppliers and supporting in supplier non-conformance resolution.
- Proactively assist the BU and manufacturing sites to investigate and address QI/SCARs and ongoing issues with suppliers.
- Ensure all non-conformance, CAPA and SCARs are investigated effectively and efficiently to meet required timelines and are fully compliant with our procedures and documented in our quality management system.
- Work collaboratively with teams across the BU to resolve supplier quality issues and serve as point of contact for those issues.
- Support in the set-up of suppliers on the quality management system.
- Supports in tracking and trending activities for supplier quality issues and overall supplier performance.
- Actively stays current with external and internal quality systems standards and requirements providing quality systems support to the Galway Legal Manufacturer (LM).
- Possesses and applies a broad and increasing knowledge of Quality, and its application within the IDEM Business Unit.
- Identifies deficiencies in quality systems and defines systematic corrective actions. Supports the continuous improvement of quality system processes.
- Supports in the development of effective quality metrics and communicates results to key stakeholders. Assists in the preparation and maintenance of records associated with the management review process.
- Applies problem-solving skills in order to deal creatively with moderately complex situations, work that typically requires processing and interpreting, more complex, less clearly defined issues. Identifies problems and possible solutions and takes appropriate action to resolve.
- Drives compliance cross functionally in alignment with the Business Unit objective for standardization and collaboration.
- Update and create quality procedures as required through the change control process.
- Participate in and support internal and external and supplier audits across the business
The ideal Quality Engineer looks like:
- Third level qualification in Science/ Engineering.
- Minimum 3-4 years of experience in medical device industry
- Experience managing or communicating with suppliers would be an advantage.
- Excellent interpersonal, written and verbal communication skills, including ability to convey appropriate information with clarity and effectiveness across different cultures.
- Pro-active attitude, excellent organization skills, and ability to manage multiple tasks while delivering results on time.
- Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
- Able to travel internationally (approximately 10% annually).
- Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g., ISO9001/ ISO13485/ ISO14971/ cGMP / /IVDR/MDSAP).
- Experience with CAPA/SCAR investigation management systems.
For a confidential discussion and more information on the role, please contact Jessica Ryan,
091706719
jessica.ryan@collinsmcnicholas.ie