Sr. Quality Engineer
Ethicon, Inc., a member of Johnson Johnson's Family of Companies, is recruiting for a Senior Quality Engineer, located in Somerville, NJ.
Ethicon, Inc. is a trusted, world-wide leader in surgical care. For over a century, Ethicon has continuously introduced innovations in wound closure, general surgery, wound management, women's health and urology and aesthetic medicine that fulfill the company's vision: Restoration of Body and of Life.
The Senior Quality Engineer will be involved with the development and introduction of new Medical Devices and Combination products for Ethicon Products. This position will provide support to the development and lifecycle management of wound closure and hernia repair products including: absorbable and non-absorbable sutures, topical adhesives, surgical meshes, and wound drains.
The Senior Quality Engineer will function as the project team lead in matters related to Quality Engineering working closely with RD, 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 develop comprehensive risk management plans for the products and processes, and ensure the delivery and utilization of effective quality strategies for validation, while ensuring the development of appropriate test methods for product and process performance. The individual will assist teams to identify critical to quality design and process characteristics/specifications. Will be often responsible for reviewing and approving plans and protocols related to design verification/validation, process validation, computer system validation, facility qualification and similar.
The Senior Quality Engineer will utilize Quality Engineering techniques such as risk analysis, measurement systems assessment, statistical data analysis, sampling plan development, and design of experiments. 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 Senior Quality Engineer will be responsible for supporting tech transfer activities internally and/or at suppliers ensuring proper application of process validation, process control, and process risk management. 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
At minimum of a Bachelor's degree is required; an advanced degree is preferred. A focused degree in Polymer Science, Chemical Engineering, Bio Medical Engineering or other related scientific discipline is required. A minimum of 5 years relevant working experience in Quality Engineering or Validation is required. Medical Device, Biopharm or Pharmaceutical (BLA, PMA, 510K or equivalent) experience is required. Knowledge and experience in bioabsorbable polymers and polymer processing technology is preferred.
Experience with New Product Development/Processes is required. Intermediate to advanced knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is required. A demonstrated working knowledge of industry regulations such as: 21 CFR 210, 211, 820, MDD, ISO 13485 is required. Working knowledge of ISO 14971 is preferred. Experience collaborating with external suppliers is preferred. Experience with Six Sigma/Process Excellence training, tools and/or certification is preferred. Working knowledge of Medical Device design controls is preferred. An ASQ Certification is preferred.
Demonstrated ability to manage 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.
This position is based in Somerville, NJ and requires up to 20% travel, potentially peaking over that amount depending on the business need.
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