Quality Engineer - NPI​/P

For immediate consideration, please apply directly to this job posting AND email me at biacosta  with the following:

• 1) word copy of resume
• 2) 2-3 professional references
• 3) 4-5 brief bullet points highlighting technical qualifications

Advocates and leads design for manufacture and assembly through technical leadership and direction in quality assurance, quality control and preventative activities. Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA. Will develop and characterise processes that are capable, scalable and produce high yield. Will support the design of robust inspection strategies including CQA’s, CTQ’s and MSA’s.

Provide quality engineering support for the execution of quality assurance activities during design transfer phases of new product development.

Will reside within the regional NPI QE team as part of GQO Quality Assurance organization and work collaboratively with Advanced Operations and Design Assurance, with responsibility for quality assurance activities, including, but not limited to the following:

Foster collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with design transfer activities.

Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.

Mentor other groups and functions on areas of expertise with particular attention to design and process transfer.

Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates. Analyzes reports and defective products to determine trends and recommend corrective actions.

Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.

Proficient in risk management practices and tools, having high expertise in failure modes associated with production and production related processes, (PFMEA).

Support the Risk Management File through risk Management Principles. Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle (at supplier, incoming of materials/components, manufacturing, until product release) through robust pFMEA.

Ensure all Risk Management outputs comply with ISO
14971.

Support Design team to complete CQA/CTQ identification and inputs to dFMEA to enable process risk identification, process characterization, process capability and robust process control.

Develop and implement lean inspection strategies and inspection plans through state-of-the‑art inspection methods and technologies. Ensure inspections are repeatable, efficient, and scalable.

Lead continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination.

Lead First Article Inspection (FAI) Strategies, both internally and externally, and approve First Article Inspections. Optimize inspection costs through lean initiatives while maintaining safety, integrity, and reliability of the product.

Develop Measurement System Analysis (MSA) strategy and approve executed MSAs.

Support the development, execution, and approval of validation strategies, with the goal of highly capable processes, that result in high yield and enable scalability. Approve protocols and reports, including data analysis.

Influence processes towards validation versus manual verification, where possible.

Support Sterilisation validation activity, as required.

Apply appropriate statistical…