STAFF DESIGN QUALITY ENGINEER

Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson.
We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.
Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo Staff Design Quality Engineer Permanent Contract Galway, Ireland Job summary To provide QA 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.
Responsible for supporting the Design and Development of product in compliance with the CERENOVUS Quality System and in line with Johnson & Johnson policies and standards to enable compliant growth and the design/manufacture of robust high quality products.
Works closely with the R&D, Regulatory, Supply Chain, Clinical and Marketing functions in creating/maintaining quality systems for product design and product launches and business needs.
Responsibilities & Accountabilities 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 CERENOVUS Design control and Risk Management activities, wherever they are performed comply with the requirements of the CERENOVUS Design Control and Risk Management processes.
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 Engineer resources to support CERENOVUS business objectives.
Resolve project issues by working with team members, suppliers, and others as appropriate.
Apply detailed, 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.
Generation/provide input for the development of risk management file documents; Risk Management Plan, dFMEA, pFMEA and associated reports.
Provide recommendations into development of protocols / reports supporting the Design Control process.
Provide recommendations and review to protocols and reports for sterilization, biocompatibility and packaging validations.
Co-ordination of timely review and approval of all details in R&D batch sterilization records as meeting the requirements of the cycle validated and appropriate for the CERENOVUS product.
Co-ordination of 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 the need arises.
Support the translation of the design requirements into manufacturing requirements.
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 Neuravi quality system (e.
.
CAPA).
Preparation of data as applicable for use in management review.
Act as an audit escort and/ or support co-ordination of backroom activity during inspections as required.
Support regulatory activities as requested by Management.
Compile and conduct Quality System training for employees as advised, Represent CERENOVUS expertly and positively externally to agencies, vendors and regulators.
Responsible for communicating business related issues or opportunities to next Management level.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed Qualifications Education and Experience A minimum of a Bachelor’s Degree is required, preferably in Engineering or related technical field.
Minimum 6 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, Sterilization and Quality Assurance processes.
Experience in preparation, participation and response to external agency inspections e.
.
FDA and Notified Body Inspections Required knowledge, skills, abilities, certification/licenses Detailed knowledge of Design Control requirements and processes.
Detailed knowledge of 21 CFR 820, ISO with knowledge of foreign medical device quality system requirements.
Must be highly organized with the ability to work on multiple projects/tasks simultaneously and remain agile given changing priorities.
Ability to work under pressure achieving consistently high results through individual and team efforts.
Highly motivated and a hardworking self-starter with the ability to work under own initiative and as a great teammate.
Ability to build good, strong and positive working relationships with multi-functional teams both locally and internationally.
Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely multifaceted audience.
Ability to discern major quality issues.
Lead Auditor Qualification is helpful.
Working at Johnson & Johnson 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 and every one of our people feels that they belong and can reach their potential.
No matter who they are.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.