Description
I have an immediate opening for Senior Quality Engineer (€50K- €60K) with a growing medical device company in Galway who are about to embark on a exciting major expansion project.The Senior Quality Engineer will work with the subcontract manufacturer teams to ensure all manufacturing processes, materials and products are supported from a quality and compliance perspective. This person will have significant experience in working in multi-functional teams managing New Product Introductions and supporting Operations. Experience within Process Validation and Supplier management is highly desired.
Responsibilities:
- Working with the subcontractor operations team to support manufacturing operations.
- Management of critical outsourced subcontractors and suppliers as follows:
* Planning and managing key suppliers to deliver product in line with the Company's business requirements
* Managing company's relationship with key suppliers to assure reliability of supply and quality of product
- Generation and maintenance of Master Validation Plans, FMEAs, IQ/OQ/PQ protocols and reports as required for New Product Introductions / Process Improvement Activities.
- Optimisation of manufacturing processes to ensure robustness of supply
- Working within the quality system and ensuring that the company systems and procedures are complied with in line with the Medical Device Directive 93/42/EEC, Medical Device Directive /EC, ISO 13485, FDA Quality System Regulations 21 CFR Part 820 and ISO 14971.
- Participate in the company's audit and CAPA programs as follows:
* Raise CAPAs, as required, and manage timely and effective resolution of assigned actions
* Performing internal and external audits to ISO and FDA requirements
* Act as a company representative during audits of areas of assigned responsibility.
- Investigation of customer complaints and co-ordination with manufacturing subcontractors, where necessary.
- Participate in assigned project team activities as follows:
* Represent the requirements of the quality system and regulations in relation to all project activities.
* Interpret new or existing quality/regulatory requirements as they relate to assigned projects.
- Participate in regulatory submission compilations
Requirements:
- A minimum of five years relevant experience in the medical device or pharmaceutical industry.
- Excellent analytical skills.
Good familiarity with sampling, validation and physical testing
- Excellent communication and organisational skills.
- Computer literacy and the ability to present reports neatly and accurately.
- A thorough understanding of ISO13485 and the FDA QSRs is a prerequisite.
This really is an excellent opportunity with a fantastic innovative company. If you are interested in hearing more about this opportunity please apply directly to this advert or contact Derek Sheridan on for further details.