Job Title: Staff Design Quality Engineer
Department: Quality
Reports To: Quality Manager
Closing Date: 26th September 2024
CERENOVUS Ireland, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Design Quality Engineer.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver significant solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we cultivate a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
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 ongoing business needs.
Duties & responsibilities
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 and Life Cycle Management projects.
• Contribute and participate in design review meetings.
• Generation/provide input for the development/update of risk management file documents; Risk Management Plan, d FMEA, p FMEA and associated reports.
• Provide recommendations/ develop protocols / reports supporting the Design Control process.
• Provide recommendations and review to protocols and reports for sterilization, biocompatibility and packaging validations.
• Co-ordination/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/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 CERENOVUS quality system (e.g. 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 internal and supplier audits as the need arises.
• Support regulatory activities as appropriate for projects and life cycle management activities or 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

SECTION 3: EXPERIENCE AND EDUCATION*

• A minimum of a Bachelor’s Degree is required, preferably in Engineering or related technical field.
• Minimum 6 year' 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

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Detailed knowledge of Design Control and Risk Management requirements and processes.
• Detailed knowledge of 21 CFR 820, ISO13485 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 varied audience.
• Ability to discern major quality issues.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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