QA Project Engineer

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting a QA Project Engineer to join our contingent workforce on a growing team in Depuy Synthes Cork for an initial 12 month contract. 

About Depuy Synthes

DePuy Synthes, Companies of Johnson & Johnson, is the largest, most comprehensive

orthopedic and neurological business in the world, built upon the strong legacies of two

great companies.

DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and

programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological,

cranio-maxillofacial, power tools and biomaterials.

Our broad array of inspired, innovative and high-quality offerings helps advance the health

and the wellbeing of people around the world.

The Role:  

Reporting to the QE Leader, the Technology Transfer Engineer shall lead from a Quality perspective. The job holder will lead the QA element of process / technological improvements, new product introduction and product transfers in conjunction with local Quality, Operations and DePuy R&D personnel ensuring timely communication to all stakeholders to effect successful project completion.
 

Key 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 products/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 day
• Provide 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.
• Maintain a good level of house-keeping in designated areas, and observe all Health and Safety at work requirements.

Candidate Requirements:

• A Bachelor's Degree or similar qualification in mechanical or industrial engineering
• Minimum 5 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.

If you meet our requirements and are interested in hearing more about our QA Project Engineer, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!