Job Function
Quality.
Job Sub Function
R&D/Scientific Quality.
Job Category
Professional.
All Job Posting Locations
Galway, Ireland.
Job Description
At Johnson & Johnson MedTech, we’re redefining the future of healthcare by combining biology and technology to deliver smarter, less invasive, and more personalized treatments.
We are currently seeking a Senior Design Quality Engineer to join our Neurovascular team at Neuravi, where your expertise will directly impact patient outcomes and drive quality excellence across our operations.
Responsibilities and Impact
Ensure design control and risk management activities comply with the requirements of the Design Control and Risk Management processes.
Act as a Design Quality team member 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 worldwide markets.
Guide product development teams on efficient and effective application of design controls and risk management.
Work 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.
Ensure identification of critical‑to‑quality requirements, translate them into design and processing specifications.
Develop risk management processes by establishing risk control measures to ensure devices meet intended safety and performance requirements and drive continuous improvement.
Manage and complete quality deliverables for R&D projects.
Provide quality support and guidance to R&D project leads and team members.
Direct and support Design Quality Engineers and Quality Engineers.
Coordinate the Design Quality Engineering resources to support business objectives where necessary.
Proactively engage 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.
Maintain the records related to design control projects.
Contribute and participate in design review meetings.
Coordinate timely review and approval of all details in R&D batches, including sterilization records, meeting cycle validation requirements appropriate for products.
Support bench test activity as required.
Monitor data from Quality Management Systems and provide immediate feedback to quality management on deviations or issues of concern.
Lead and/or facilitate compliance and improvement activities associated with the Quality System (e.g., CAPA/non‑conformance).
Prepare data for use in management review.
Act as an audit escort or support coordination of back‑room activity during inspections as required.
Support internal and 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.
Communicate business‑related issues or opportunities to the next management level.
Collaborate with the Regulatory Affairs team and prepare 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 and cross‑functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.
If supervising staff, ensure subordinates follow Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
Ensure personal and Company compliance with all federal, state, local and Company regulations, policies, and procedures.
Perform other duties assigned as needed.
Essential Requirements
Minimum 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.
Demonstrates an understanding of AI concepts and frameworks, including responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity.
Required Knowledge, Skills, Abilities, Certifications, Licenses and Affiliations
Thorough knowledge of Design Control requirements and processes.
Thorough knowledge of Risk Management.
Working knowledge of 21 CFR 820, ISO 13485 with familiarity of other foreign medical device quality system requirements.
Ability to handle multiple projects simultaneously and 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 strong and positive relationships with cross‑functional teams internationally.
Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.
Primary Location
Galway, with flexibility to perform some of the role remotely. Anticipated 5–10 % travel (international).
Required and Preferred Skills
Required: Agility, Jumps, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Database Backup, Data Savvy, Disruptive Innovations, Issue Escalation, Problem Solving, Process Oriented, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing.
Preferred: Agility, Jumps, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Database Backup, Data Savvy, Disruptive Innovations, Issue Escalation, Problem Solving, Process Oriented, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing.
Base Pay Range
€52,400.00 – €82,915.00 per annum.
Benefits
In addition to base pay, benefits include an annual bonus, vacation days, parental leave (minimum 12 weeks), bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, programs for financial, physical and mental health, service anniversary and recognition awards, and eligibility for several insurance plans. The exact benefits and amounts vary by location and may change.
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