Quality Engineer (EU MDR)

Quality Engineer (EU MDR)

Location: Cork, Ireland (Hybrid Working) 

Duration: 12 months 

Hours: 39

Pay rate range: Negotiable 

Imagine your next project where you will be supporting the execution of DePuy Ireland UC Quality Management System processes and deliver support for GSC projects from a quality standpoint. Reporting to the Global Quality Manager, the primary purpose of the GSC Quality Specialist is to act as the point of contact for Authorised Representative Verification activities. 

The role is also responsible for the oversight of compliance activities and for identifying opportunities for improvement within quality. 

roles and responsibilities

This person will drive the flawless and compliant execution of the assigned processes to meet customer and business needs while ensuring compliance with regulatory requirements. 

This will involve: 

• Manages specified quality system processes, drives compliant execution, and represents these processes as required at cross-functional meetings.

• Works directly with various customers of the quality system processes to ensure compliance to all regulatory requirements. 

• Compiles, contextualises, evaluates, and presents Quality Systems data and metrics as required. 

• Utilises quality tools to track, trend and communicate quality performance metrics in presentations/reports/dashboards.

• Identifies personnel that require training on the relevant processes and rolls out training as required.

• Proactively examines/reviews systems and processes, to identify/assess areas for review, improvement, change, or elimination and with specific focus on simplifying and standardising processes. 

• Supports the assigned processes during internal and external audits.

• Responds to and drives/participates in investigations and corrective action implementation for identified quality issues.

• Keeps up to date with all new legislation and regulation standards for all countries and ensure compliance to any changes to these across the business.

• Assists in creating a culture of quality awareness and communicating the quality management system, GMP and associated documents and procedures to all staff.

• Assists as needed with Regulatory Affairs activities as part of the Authorised Representative function 

• Performs other duties assigned as needed.

• All employees are responsible for minimising both the environmental and Health and Safety effects of the work they perform.

how to succeed

You will be proficient in applicable GMP/QSR regulations and in- depth knowledge of Quality Systems and have 3 years of related experience in a regulated industry environment.

You will also bring:

• A third level qualification (preferably Science or an Engineering related discipline) 

• Experienced in working within medical devices is preferred but will also consider candidates from food & pharmaceutical industries within a highly regulated environment. 

• Ability to work on your own initiative with high attention to detail.

• Ability to successfully manage multiple projects and priorities.

• Ability to define problems, collect data, establish facts, and draw valid conclusions.

• Demonstrate excellent communications skills to drive the flawless and compliant execution of the assigned processes to meet customer and business needs while ensuring compliance with regulatory requirements

• Good/ advanced skills in Microsoft office and windows

Benefits

This role offers a very competitive hourly rate. This contract will run for a minimum of 12 months and has a strong chance of extension.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about DePuy Synthes

DePuy Synthes is the orthopaedic and neurological businesses of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare company. At DePuy Synthes we specialise in our innovations in healthcare products, services and programs that make a real difference to millions of people across the world. We specialise in joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgery and sports medicine, and also the VELYS™ Digital Surgery portfolio. Contribute to the next healthcare breakthrough with your next project at DePuy Synthes. 

https://www.jnjmedtech.com/en-US/companies/depuy-synthes

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, Limited & Umbrella options are available. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.