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.
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 & ResponsibilitiesResponsible for ensuring CERENOVUS Design control and Risk Management activities 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.Generate/provide input for the development/update of risk management file documents; Risk Management Plan, dFMEA, pFMEA 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-ordinate/timely review and approval of all details in R&D batch sterilization records.Co-ordinate/timely review and approval of production records and sterilization records of product manufactured during the design control process.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.Lead and/or facilitate 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 needed.Support regulatory activities as appropriate for projects and life cycle management activities.Compile and conduct Quality System training for employees as advised.Responsible for communicating business-related issues or opportunities to the 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.QualificationsA minimum of a Bachelor's Degree is required, preferably in Engineering or related technical field.Minimum 6 years of 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 AffiliationsDetailed 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.
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