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Quality Engineer

I7648

Quality Engineer required for contract position with Multinational Medical Device facility in Cork

Category:
Control Quality
Location:
Munster
Years of Experience Req.:
1 years +
Date Posted:
17/07/2019
Days Remaining:
11
Employment Type:
Contract
Education Level Req.:
Third level qualification

Quality Engineer

 

Job Purpose:

Support the QA element of process / technological improvements, new product introduction and product transfers in conjunction with local Quality, Operations and R&D personnel ensuring timely communication to all stake holders to effect successful project completion.

 

Responsibilities:

Represent Quality as part of a cross functional team to ensure delivery of projects (NPI’s and Technology) into production with the highest level of quality, compliance, and adherence to timelines

Compile and execute validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material

Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in production

Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity

Liaise with R & D to ensure Critical to Quality Characteristics are agreed and documented for all New Product Development

Lead Design for Inspection activities for all New Product Introduction to ensure latest technology is available to reduce Human Error

Lead QA input to Design for Manufacture activities on site

Ensure daily and project compliance with all Documented Quality systems i.e. FDA QSR’s and ISO 13485/9001 requirements etc. during all day to dayProvide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions

Assist in problem solving for new products and established production process enabling reduction in compliance risks, scrap and reprocessing

Assist in the development, review and approve product, gauge, tooling and fixturing drawings

Requirements

A degree level or similar qualification in mechanical or industrial engineering

Minimum 1 years experience in a quality role within a regulated industry

Proven ability to successfully introduce new product development in the Medical Device Industry

Proven knowledge and ability regarding product verification and process validations

Proven knowledge of FDA and MDD GMP requirements regarding medical Devices

Proven experience and training in Mechanical Engineering processes

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Quality Validation Engineer