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**Job Function: **
Quality
**Job Sub Function: **
R&D/Scientific Quality
Job Category:
Professional
All Job Posting Locations:
Galway, Ireland
Job Description:
About MedTech
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. Join us in shaping the next generation of medical innovation.
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.
As a Senior Design Quality Engineer
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.
**The responsibilities and the impact YOU will have: **
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
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 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 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
· Performs other duties assigned as needed.
We would love to hear from YOU, if you have the following essential requirements:
- 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
Demonstrates an understanding of AI concepts and frameworks, including awareness of 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, 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.
Primary location – Galway, with flexibility to perform some of the role remotely.
· Anticipated 5-10% travel (international).
**Required Skills: **
Preferred Skills:
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
The anticipated base pay range for this position is:
€52,400.00 - €82,915.00
Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.