Senior Design Quality Engineer – Neurovascular team, Johnson & Johnson MedTech.
Responsibilities
Responsible for ensuring Design control and Risk Management activities 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.
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 and translate them into design and processing specifications.
Develop 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 and guidance to R&D project leads and team members.
Provide direction and support to Design Quality Engineers and Quality Engineers.
Co‑ordinate 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.
Manage and maintain records related to design control projects.
Contribute to and participate in design review meetings.
Co‑ordination and timely review and approval of production records and sterilisation 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.
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 and/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 lifecycle 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 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 as well as cross‑functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.
For those who supervise or manage staff, ensure 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.
Ensure personal and company compliance with all federal, state, local, and company regulations, policies, and procedures.
Perform other duties assigned as needed.
Qualifications
Minimum education of a degree in a technical field is preferred.
Minimum of 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, sterilisation 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.
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 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.
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
Primary location – Galway, with flexibility to perform some of the role remotely.
Anticipated 5‑10% travel (international).
Pay Range
€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, 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, service anniversary and recognition awards, and, subject to the terms of their respective plans, employees (and in some locations’ eligible dependents) can participate in several insurance plans.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
#J-18808-Ljbffr