IRL - Quality Engineer - Senior

JOB TITLE: Senior Quality Engineer                  Pay Grade: 25
Company/Group Overview
Medical Devices & Diagnostics Global Services, LLC., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD&D Supply Chain supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
Position Overview
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.
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.
Major Responsibilities & Duties:
Business Improvements
?   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.

Compliance/Regulatory
?   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 and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality

Product/Process Qualification
?   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.

Risk Mitigation
?   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

Strategic
?   Ensures effective quality strategies are created for the validation of test methods, process and design.


Qualifications

?   A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 4-6 years related experience.
?   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.
?   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. The ability to think on the feet and providing sound judgment is highly desired.
?   Good technical understanding of manufacturing equipment and processes 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 are required.
?   Continuous Improvement Focus