Ethicon, Inc., a member of the Johnson & Johnson's Family of Companies, is recruiting for a Staff Process Quality Engineer to be located at Cornelia, GA.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation.
SUMMARY: The Staff Process Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. The Staff Process Quality Engineer will also utilize Quality Engineering Principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve processes capability.
• The areas of support include Synthesis Processes for Absorbable Polymers, Raw Materials, Extrusion Processes, and Fiber and Textile Processes.
• Lead or support manufacturing process development and improvement activities.
• Define root cause and implement solutions to equipment and process related non-conformances utilizing the non-conformance and CAPA processes.
• Make decisions independently on engineering problems and methods and prepare technical reports and project updates for the team and senior management.
• Design and perform process development experimentation using Design Of Experiments (DOE) and develop and review manufacturing process validation documentation.
• Lead, support, and/or develop and execute equipment or process related validations in accordance with Ethicon requirements, processes, and procedures.
• Participate in formulating quality / performance standards of product / processes.
• Prepare process development, process validation, and material qualification protocols.
• Execute and or Approve IQ, OQ/ PQ, TMV, and/or Software Validations.
• Develop, interpret, and implement standard and non-standard sampling plans.
• Develop, interpret, and implement appropriate process monitoring and control methods.
• Assess and interpret common versus special cause variation in manufacturing processes.
• Partner with R&D and other cross functional partners to ensure the proper application of design controls, risk management, and the investigation/correction of design failures/challenges.
• Collect data and execute/conduct various analytical/statistical analysis and interpret results.
• Propose and implement improvement projects that improve quality, compliance, efficiencies, yields, or throughputs.
• Provide Process & Controls Engineering Leadership and support for manufacturing processes and equipment.
• Develop new and/or improve existing products and processes applying automation, robotics, and vision systems.
• Serve as a consultant in area of expertise to the other personnel and as a supervisor or facilitator of technical personnel, if required.
• Develop the necessary equipment, processes and product knowledge to be recognized as a local expert, particularly in areas of control engineering, maintenance, calibration, robotics, and vision systems.
• Supports new product introduction as part of design transfer.
• Observe all regulatory requirements such as Good Manufacturing Practices (GMPs), ISO, FDA, and internal policies applicable to their area of responsibility and comply with Johnson & Johnson Safety/Environmental requirements and safe working conditions and practices.
• OTHER RESPONSIBILITIES:
• Perform other work-related duties as assigned by supervisor/manager.
• Work in team environment behaving in a CREDO based respectful manner.
• Adhere to J&J environmental and safety policies and guidelines.
• Comply with all job specific safety procedures and utilize PPE when necessary.
• Comply with quality system requirements as defined within procedures and instructions.
• Utilize applicable software systems as needed for the job (e.g. ComplianceWire, ADAPTIV, etc.)
• Consistently meet required Training due date targets.
• Support efforts to develop and sustain a culture of waste reduction and affect an ongoing and sustained improvement in product and process quality.
• Ensure fulfillment of all regulatory, safety, industrial hygiene and environmental requirements for implementation of new products, processes, and equipment.
• Assist in preparation of annual budget, including identification of new projects to drive growth and cost control for both enterprise and operating company success.
• Originate Capital Appropriation Requests (CAR) for capital required for project work.
• Drive identification and successfully implement cost improvement projects (CIP).
• Accountable for assuring product and equipment designs are capable of meeting Ethicon, Inc. quality standards.Qualifications
• A minimum of a Bachelor’s degree in an Engineering technical field is required; Biomedical, Mechanical, Chemical Engineering and or Material Science, or other related are highly preferred
• A minimum of 6-8 years related experience is required
• Prior experience in a GMP or medical device manufacturing environment is preferred.
• Technical training and experience using statistical software packages is preferred
• Technical understanding of chemical manufacturing equipment and polymerization processes is preferred.
• Proven experience in using Design of Experiments to improve product and processes is required
• Six Sigma Black Belt certification or Certified Quality Engineer equivalent is preferred
• Statistical and analytical problem solving is required.
• Knowledge of lean manufacturing and manufacturing processes is preferred.
• Knowledge of SPC is an asset.
• Ability to initiate and manage change as well as build effective teams across manufacturing and support areas in multiple facilities.
• This position may require up to 10% travel and will be based in Ethicon Cornelia, GA manufacturing facility.
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J2W: LI NAPrimary Location
Ethicon Inc. (6045)Job Function
Quality (Eng)Requisition ID
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