NPI Quality Engineer

Azon are delighted to be teaming up with a multi-national biomedical device company. They are looking to expand their Quality team with an experienced, creative and motivated candidate.

The successful candidate would have experience in the process of introducing new biomedical products to market. They should have an in-depth understanding of all the regulations and legislation associated with the design through to maintenance and support of the product.

This company established itself in Ireland just over 10 years ago and continues to grow as an industry leader in the biomedical world. This position is located in Galway and is a 12-month fixed-term contract with the possibility of extension along with a range of appealing benefits.

Responsibilities:

• Formulates procedures, specifications, and standards for products and processes.
• Provides leadership for quality engineering projects from concept through design, implementation, testing, documentation, support, and maintenance.
• Develops and implements corrective/preventative action plans.
• Collects and analyzes data for gauge and product evaluation.
• Develop and maintain an effective and robust quality system which complies with all relevant regulatory requirements.
• Ensure all validation activity is effective and documented in a compliant manner.
• Complete in-depth investigations into, product non-conformance’s, customer complaints and implement corrective and preventative actions, as appropriate.
• Identifies critical personnel, gauges, procedures, and materials needed for the completion of new products.
• Ensures that suppliers have necessary information and facilities to deliver quality products to Zimmer.
• Certifies product builders to ensure they have the required skills to complete their operation.

Requirements:

• Third Level Degree in Quality or Engineering field.
• 2 years relevant experience in a relevant quality technician role.
• Excellent communication and influencing skills.
• Microsoft Office Suite.
• Understanding of QSR/ISO regulations.
• Risk assessment skills using FMEA methodology.
• Product testing methods, and able to use hard gauging and optical comparators.
• Knowledge of statistics, process control, and process capability.
• Demonstrated NCR / CAPA experience.
• Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
• Facilitates team efforts on quality engineering projects.
• Ability to deliver, meet deadlines and have results orientation.
• Able to communicate both orally and in written form to multiple levels of the company.