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Senior Quality Engineer
Requisition ID: 8052171222
Ethicon, Inc., a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Senior Quality Engineer in Cornelia, GA.
The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars, energy devices and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. 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 surgery.
The Senior Quality Engineer plans, conducts and directs engineering projects or studies including complete projects requiring advanced knowledge of a specialized field. They apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas. They may coordinate and direct activities of technical support staff and are responsible for technical development of assigned staff.
You will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. You will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that align with the overall Quality and Business vision. He/she will utilize risk management to prevent failure modes and improve capability of processes. This person will support processes in base business.
Major Responsibilities & Duties:
- Support quality initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- Conduct benchmarking to develop more effective methods for improving quality
- Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
- Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
- Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
- Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
New Product/Process Introduction
- Partners 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.
- Supports new product introduction as part of design transfer.
Product Quality, Control & Disposition and Performance Standards
- Lead and maintain Material Review Board.
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
- Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
- Accountability of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
- Approve IQ, OQ, PQ, TMV or Software Validation
Production/Process Controls including Control Plans
- Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
- Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan
- Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
- Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
- Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
- Develop, interpret and implement standard and non-standard sampling plans
- Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
- Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data.
- Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
- Document, rationalize, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
- Ensures effective creation of quality strategies for the validation of test methods, process and design.
- Work in team environment behaving in a CREDO based respectful manner.
- Adhere to J&J environmental and safety policies and guidelines, while complying with all federally regulated programs and quality system requirements as defined within procedures and instructions.
- Use test equipment (Starett Gauge, Mitutoyo Gauge, Microscope, etc) where applicable.
- Utilize applicable software systems as needed for the job (e.g. ComplianceWire, ADAPTIV, etc.)
- Consistently meet required work performance targets (RE’s), if applicable
- Support LEAN and Six Sigma Initiatives.
- Support Maintenance Excellence (ME2) including 6S and Operator Asset Care.
- Accurately complete records as defined within the job procedures (e.g. manual and/or electronic documentation).
- Consistently meet required Training due date targets.
- A minimum of a Bachelors’ Degree, preferably in Engineering or related technical field. Requires 4+ years related experience.
- Experience working in both an FDA and European regulatory environment is preferred.
- Relevant experience working in manufacturing/operations with good technical understanding of manufacturing equipment and processes is required.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Experience with a consistent track record of implementing appropriate risk mitigation.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision-making.
- The ability to perform "hands on" troubleshooting and problem solving is required.
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
- Advanced knowledge and proven leadership in the areas listed in the Duties and Responsibilities associated with the position.
- Demonstrated project management and project leadership abilities is required.
- This position may require up to 10% travel and will be based in Cornelia, GA.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.Johnson&JohnsonFamilyofCompaniesareequalopportunityemployers,andallqualifiedapplicantswillreceiveconsiderationforemploymentwithoutregardtorace,color,religion,sex,sexualorientation,genderidentity,geneticinformation,nationalorigin,protectedveteranstatus,disabilitystatus,oranyothercharacteristicprotectedbylaw.
Ethicon Inc. (6045)