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Senior Design Quality Engineer
Location:
Galway, Co. Galway
Description:
CERENOVUS a member of Johnson and Johnson's Family of companies is seeking a highly motivated individual to join our Design Quality Engineering team in Galway, Ireland. This is an opportunity to be part of a fast growing organisation that is committed to the innovation of solutions for the treatment of Ischemic and Haemorrhagic stroke. We are looking for a candidate who is a self-starter who can work independently and function well within a team. The role which supports life cycle management activities will require close collaboration with R&D, Regulatory and Supply Chain functions. 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. Responsibilities and accountabilities Under limited supervision and in accordance with all applicable regulations: * Responsible for ensuring Design control and Risk Management activities, wherever they are performed comply with the requirements of Design Control and Risk Management processes. * Provide Quality support/guidance to R&D projects leads/team members. * Provide direction and support to Design Assurance engineers and Quality Engineers. * Co-ordinate the Design Assurance Engineer resources to support business objectives. * Resolve project issues by working with team members, suppliers, and others as appropriate. * Apply systematic problem-solving methodologies in identifying, prioritising, presenting, and resolving quality issues. * Manage and maintain the records related to design control projects. * Contribute and participate in design review meetings. * Generation and maintenance of risk management file documents; Risk Management Plan, dFMECA, pFMECA and associated reports. * Provide Design Quality support related to the full life cycle of products. * 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. * 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. * 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. * 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.g. CAPA). * 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. * Perform internal/Supplier audits as scheduled and maintain Cerenovus internal audit records. * Support regulatory activities as requested by management. * Compile and conduct Quality System training for employees as advised, * Represent the Company expertly and positively externally to agencies, vendors and regulators. * Responsible for presenting business related issues or opportunities to next level management. * Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures * Performs other duties assigned as needed * A minimum of a Bachelor's Degree is required, preferably in Engineering or related technical field. * Minimum 3 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.g. FDA and Notified Body Inspections Essential knowledge, skills, abilities, Certifications/Licenses and Affliations. * Detailed knowledge of Design Control requirements and processes. * Understanding of 21 CFR 820, ISO13485 with familiarity of other 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 internationally. * Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely multifaceted audience. At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, 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/.
Company:
Johnson And Johnson
Posted:
June 27 on Equest
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More About this Listing: Senior Design Quality Engineer
Senior Design Quality Engineer is a Quality Assurance Quality Engineer Job at Johnson and Johnson located in Galway G. Find other listings like Senior Design Quality Engineer by searching Oodle for Quality Assurance Quality Engineer Jobs.
Senior Design Quality Engineer is a Quality Assurance Quality Engineer Job at Johnson and Johnson located in Galway G. Find other listings like Senior Design Quality Engineer by searching Oodle for Quality Assurance Quality Engineer Jobs.