Description
Quality Engineer - Cork - €24 - €27 Per Hour - 12 Months
The Senior Quality Engineer plans, conducts and directs engineering projects or studies including complete projects requiring advanced knowledge of a specialized field. They apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas. They may coordinate and direct activities of technical support staff and are responsible for technical development of assigned staff. The Senior Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product life cycle. The incumbent will also utilize Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.
Responsibilities & Duties:
Support quality improvement initiatives such as process and product characterizations that lead to continuous/cost improvements.
Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
Conduct benchmarking to develop more effective methods for improving quality
Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
Champions compliance to applicable Global Regulations and standards (eg QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality Product/Process Qualification
Approve IQ, OQ, PQ, TMV or Software Validation Production/Process Controls including Control Plans
Qualifications:
Bachelors Degree, preferably in Engineering or related technical field.
In-depth knowledge of product/process Risk Management (FDA and ISO standards).
Experience with a proven track record of implementing appropriate risk mitigation.
Technical training and experience using Statistics, Lean and Six Sigma Methodologies including Measurement System Analysis, SPC, DOEs, Reliability, etc.
Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
The ability to perform "hands on" troubleshooting and problem solving is required. The ability to think on the feet and providing sound judgment.
Good technical understanding of manufacturing equipment and processes
Understanding of the NPI (New Product Introduction) process and Process Validation
A thorough understanding of GMP/ISO regulations and validation regulations.
Continuous Improvement Focus
Additional information about the process:
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.