Process Quality Engineer

Job Description

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 the activities of technical support staff and are responsible for the 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 the capability of processes. This person will support processes in the base business.

Major Responsibilities & Duties:

• 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.
• Support the complete process verification activities and should have a completed understanding of Validation documents.
• Support on the Equipment IQ, OQ & PQ.
• Support the new test method development and validation.

Business Improvements

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• 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 skillsets for new product introductions, and product life cycle management.

Compliance/Regulatory

• Analyze whether current products and processes (including actions or decisions conducted) comply with standards such as the QSRs, ISO 13485, etc.

Quality, Control & Disposition and Performance Standards

• Analyze/review the 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

Production/Process Controls including Control Plans

• 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 interpretations as part of process improvements and day-to-day support.
• Develop, interpret and implement standard and non-standard sampling plans
• Assess the effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
• Accountability and ownership for sampling plans of all types including the 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 standards for manufacturing data.
• Assess and interpret common versus special cause variation in manufacturing processing and determine the 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 the capability of current controls or whether the 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 the effectiveness of these techniques on previously implemented improvements

Strategic

• Ensures effective quality strategies are created for the validation of test methods, processes and design.

Qualifications

• A minimum of a Bachelor's Degree, preferably in Engineering or a related technical field. Generally, requires 4-6 years of 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 are 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 provide 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.

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