Johnson & Johnson Diabetes Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Engineer for West Chester, PA.
The Johnson & Johnson Diabetes Care Companies (JJDCC) includes blood glucose monitoring systems (LifeScan, Inc.), insulin delivery systems (Animas Corporation and Calibra Medical), and healthcare professional product training and educational programs to improve care and outcomes (The Johnson & Johnson Diabetes Institute). The JJDCC are committed to creating a world without limits for people with diabetes by offering innovative products and services to best serve their needs. The JJDCC culture is founded on the principles of the Johnson & Johnson Credo, Johnson & Johnson Leadership Imperatives and three JJDSC values: We Care About Everything We Do; We Execute with Excellence and Keep Our Promises; and We Compete as One.
The Senior Quality Engineer plans, conducts and directs engineering projects or studies including completing 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.
The Senior 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 incumbent 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 capability of processes. This person will support processes in base business.
- Support quality improvement 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
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 and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.
- Establish and monitor metrics relative to Lean Six Sigma programs, projects and initiatives.
- Responsible for the application of Lean Six Sigma techniques in pursuit of continuous improvement and for delivering tangible bottom line result.
Approve IQ, OQ, PQ, TMV and 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, justify, 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.
Minimum of a Bachelor’s Degree, preferably in Engineering or related technical field.
4-6 years related experience in a Medical Device or equivalent regulated industry.
Experience working in both an FDA and European regulatory environment is preferred.
This position will require relevant experience working in manufacturing/operations.
In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
Experience with a proven 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.
Six Sigma Green Belt Certification is preferred
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.
Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
Experience with Risk Management (ISO 14971), Gage repeatability and reproducibility theory and application, statistics, project management (supporting multiple projects simultaneously), and reliability is preferred.
ASQ certification (CQE, CQM, CRE, CQA) is preferred.
United States-Pennsylvania-West ChesterOrganization
Animas Corporation (6150)Job Function