New Technology Process Quality Engineer

New Technology Process Quality Engineer

Location:

Raynham (MA) Salary range that TCS can offer to the candidate: $75K-$88K per year.

The Quality Engineer will actively support new product development as well as front end manufacturing technology and inspection technology feasibility studies. As part of this, this individual will work on small cross functional teams and lead/facilitate planning, conducting and directing engineering projects or studies, including complete projects requiring knowledge of a specialized field. They apply knowledge of engineering principles and practices within assignment areas.

The Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development 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 early phases of development. Applies advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, GxP requirements, and industry best practices to assignments.

• Support quality improvement initiatives such as process and product characterizations that lead to cost improvements / cost avoidance.
• 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 (MD) 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.
• 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 activities including early process concept development.
• Partners with Pharmaceutical 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.
• Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
• Develop Components of Variation (COV) studies and any applicable Design of Experiment (DoEs) as required for front end feasibility and process development
• Explore relevant inspection and manufacturing technologies that meet needs of an NPD project
• 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.
• 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…