Senior Design Quality Engineer

Senior Design Quality Engineer 

Location: Galway - Hybrid working - 3 days a week on site

Duration: Until December 2025

Hours: 39 per week

To provide Design Quality technical and compliance expertise as part of teams tasked with  establishing customer needs, developing new products and/or modifying existing designs.  Assure compliance to applicable regulations and lead quality activities such as risk  assessments, device testing, audits, procedure development, documentation review and  changes to controlled documents. Provides design control, risk management and  compliance support for product design and manufacturing, corrective and preventive  actions, product/process improvements and complaint investigations. 

roles and responsibilities

• Responsible for ensuring Design control and Risk Management activities, wherever  they are performed comply with the requirements of the Design Control and Risk  Management processes. 

• Design Quality team members focused on new product development and lifecycle  management activities. 

• Provide leadership in the understanding of medical device regulations to other  disciplines, specifically compliance to Design Control Regulatory requirements in  world-wide markets.  

• Guide product development teams on efficient and effective application of design  controls and risk management.  

• Works with design team in the identification of design input, establishment of design  outputs, failure mode prevention, test method development and validation for design  verification and validation activities, competitive testing, process validations, design  transfer and launch planning  

• Ensures identification of critical to quality requirements, translate them into design  and processing specifications.  

• Develops risk management process by establishing risk control measures to ensure  devices meet intended safety and performance requirements and drive continuous  improvement

• Responsible for the management and completion of Quality deliverables for R&D  projects. 

• Provide Quality support/guidance to R&D projects leads/team members. 

• Provide direction and support to Design Quality Engineers and Quality Engineers. 

• Co-ordinate the Design Quality Engineering resources to support business objectives where necessary. 

• Proactively engages partners to drive consensus and resolve issues in a timely  fashion. 

• Apply thorough, systematic problem-solving methodologies in identifying,  prioritising, communicating, and resolving quality issues. 

• Manage and maintain the records related to design control projects. 

• Contribute and participate in design review meetings. 

• Co-ordination/timely review and approval of all details in R&D batches including sterilization records as meeting the requirements of the cycle validated and  appropriate for products. 

• Co-ordination/timely review and approval of production records and sterilization  records of product manufactured during the design control process to facilitate timely  approval of Design protocols and reports. 

• Support bench test activity as required. 

• Ongoing monitoring of data from Quality Management systems and provision of  immediate feedback to quality management on deviations or issues of concern.  

• Leads and/or facilitates compliance and improvement activities associated with the  Quality System (e.g. CAPA/non-conformance). 

• Preparation of data as applicable for use in management review.  

• Act as an audit escort and/ or support coordination of backroom activity during  inspections as required.  

• Support internal/Supplier audits as scheduled. 

• Support regulatory activities as appropriate for projects and life cycle management  activities or as requested by management. 

• Compile and conduct Quality System training for employees as directed, 

• Represent J&J MedTech Neurovascular professionally and positively externally to  agencies, vendors and regulators. 

• Responsible for communicating business related issues or opportunities to next  management level 

• Collaborates with the Regulatory Affairs team and the preparation of deliverables for  regulatory filings.  

• Support Complaints and Escalation or applicable CAPAs for recent project launches  (post Design Transfer) 

• Communicate effectively at all levels within Quality as well as cross functionally with  departments such as Product Development, Regulatory Affairs, Manufacturing, and  Marketing 

• For those who supervise or manage a staff, responsible for ensuring that  subordinates follow all Company guidelines related to Health, Safety and  Environmental practices and that all resources needed to do so are available and in  good condition, if applicable

• Responsible for ensuring personal and Company compliance with all Federal, State,  local and Company regulations, policies, and procedures 

how to succeed

We will also consider less Senior candidates for this role

• Minimum education of degree in a technical field is preferred.  

• Minimum 5 years’ experience in the medical device industry and/or IVD/pharmaceutical, with at  least three years in a position with direct responsibility for QMS processes/sub-processes. 

• Demonstrated knowledge of the application of the principles, concepts and practices of design  control, risk management, sterilization and Quality Assurance processes. 

• Experience in preparation, participation and response to external agency inspections e.g. FDA  and Notified Body Inspections 

• Ability to work cooperatively with coworkers and the public 

• Ability to perform duties in accordance with policies and procedures and to comply with civil  rights requirements

• Thorough knowledge of Design Control requirements and processes. 

• Thorough knowledge of Risk Management. 

• Working knowledge of 21 CFR 820, ISO13485 with familiarity of other foreign medical device  quality system requirements. 

• Ability to handle multiple projects simultaneously and to discern major quality issues. 

• Ability to work well under deadlines and pressure. 

• Ability to work on own initiative and as a team player. 

• Ability to build good, strong and positive working relationships with cross functional teams  internationally. 

• Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely  varied audience.

benefits

This role offers a very competitive hourly rate. This contract will run until December 2025 

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. 

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, LTD & 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”.