Ethicon, a member of Johnson & Johnson's Family of Companies is recruiting for a Staff Quality Engineer located in Somerville, NJ.
Ethicon Biosurgery is a leading provider of proven solutions to address a range of bleeding and leaking situations - from routine to problematic -- during surgical procedures. Our product portfolio includes proprietary oxidized regenerated cellulose hemostats; gelatin powder and sponges; a flowable hemostatic matrix; human thrombin, and fibrin sealant. Ethicon, Inc based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery.
The Staff Quality Engineer will be involved with New Product Development (NPD) and Process Introduction of new exciting Biopharmaceuticals, Medical Devices and Combination products for Biosurgery. This position will provide team member support for the development of new products as well as the validation of processes used in manufacture components and/or finished devices.
• The Staff Quality Engineer will function as the project team lead in matters related to Quality Engineering working closely with R&D, Operations Engineering, Supplier Quality Management and other cross functional members in the development and manufacture of innovative new products as well as product life cycle support.
• The engineer will be responsible for leading development of quality strategies and comprehensive risk management plans for the products and processes.
• The individual will provide leadership in assisting teams to identify critical to quality design and process characteristics/specifications.
• Individual will be often responsible for reviewing and approving plans/protocols related to design verification/validation, method validation and process validation.
• The Staff Quality Engineer will utilize routinely Quality Engineering techniques such as risk analysis, measurement systems assessment, statistical data analysis, sampling plan development, and design of experiments (DOE).
• The individual will work closely with teams leading and contributing to the improvement of device and combination product designs as well as the processes to manufacture them.
• Responsibilities of this position will include providing Quality engineering support to external suppliers and/or manufacturers. Will effectively utilize Process Excellence when possible to solve problems and develop optimal products and processes. Will provide guidance to teams to ensure compliance with company policies/ procedures as well as provide recommendations involving the implementation of regulatory requirements (e.g., cGMP, QSR, EU Directives, ISO standards, etc.).
• Additionally, the Staff Quality Engineer will support tech transfer activities internally and/or at suppliers. The QE will lead and/or support thorough investigations of quality issues (CAPAs, Deviations, audit observations & etc.) ensuring effective corrective and/or preventive actions. Will support when necessary the evaluation of potential new suppliers. Qualifications
• A minimum of a Bachelor’s degree is required. A focused degree in Mechanical, Biomedical, Chemical Engineering or other appropriate scientific discipline is required.
• A minimum of 6 years of related work experience is required. Medical Device, Biopharmaceutical or Pharmaceutical (BLA, PMA, 510K or equivalent) experience is required.
• Experience with New Product Development Processes is required. An ASQ Certification (CQE, CQA, CPGP, CMQ/OE) is preferred.
• Experience collaborating with external suppliers is preferred. Working knowledge of Medical Device design controls and ISO 14971 is preferred. Intermediate to advanced knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is required.
• A demonstrated working knowledge of 21 CFR 820, or similar industry regulations/guidelines such as: 21 CFR 210, 211, or 606, MDD, ICH Q8, Q10, or ISO 13485, is required. Knowledge and experience in aseptic processing, CIP/SIP systems, and environmental monitoring is a plus.
• Experience with Six Sigma/Process Excellence training, tools and/or certification is preferred. Experience with providing hands on quality engineering manufacturing support including the establishment of appropriate inspections/testing/sampling plans is a plus.
• Demonstrated ability to manage/lead Quality deliverables within complex projects having multiple tasks is required. Excellent verbal and written communication skills accompanied by strong collaboration and teaming skills are required. Demonstrated problem solving skills/mindset is required.
• This position is based in Somerville, NJ and may require 15 % travel, based on business needs.
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J2W: LI NAPrimary Location
United States-New Jersey-SomervilleOrganization
Ethicon Inc. (6045)Job Function
Quality (Eng)Requisition ID