Website Kasmo Inc
Kasmo Inc
Company : Kasmo Inc
Job Title: Quality Engineer – NPI / P
Job Description
As a Quality Engineer specializing in New Product Introduction (NPI), you will advocate and lead design for manufacture and assembly through technical leadership and direction in quality assurance, quality control, and preventative activities. You will support the development and introduction of new products, processes, and technologies, focusing on quality systems development, regulatory compliance, and process risk management, including pFMEA. Your role will involve developing and characterizing processes that are capable, scalable, and produce high yield, as well as designing robust inspection strategies.
Responsibilities
- Foster collaborative internal and external professional relationships across Design Divisions, Advanced Operations, and GQO functions associated with design transfer activities.
- Communicate effectively with internal customers, stakeholders, and project teams to deliver successful project transfers with high-quality standards that meet NPI project goals.
- Mentor other groups and functions on areas of expertise, particularly in design and process transfer.
- Develop and implement methods and procedures for process control, process improvement, testing, and inspection to ensure products are free of flaws and function as designed.
- Design and install sophisticated testing equipment and perform product testing and analysis to maintain quality levels and minimize defects and failure rates.
- Analyze reports and defective products to determine trends and recommend corrective actions.
- Collaborate with supplier representatives on quality problems, ensuring effective corrective actions are implemented and contribute to supplier quality improvement programs.
- Lead risk management practices and tools, focusing on failure modes associated with production and production-related processes (PFMEA).
- Ensure all Risk Management outputs comply with ISO14971.
- Develop and implement lean inspection strategies and inspection plans through advanced inspection methods and technologies.
- Lead continuous improvements of inspection methods and sampling plans, focusing on human error risk elimination.
- Support the development, execution, and approval of validation strategies, influencing processes towards validation versus manual verification where possible.
- Lead the supplier qualification strategy and approve supplier validations and Production Part Approval Process (PPAP).
- Represent quality assurance during the Design Transfer Agreement Plan (DTAP) process, ensuring product launches meet or exceed established metric targets.
- Provide subject matter expertise in Design transfer processes and procedures, participating and interfacing in internal and external audits with regulatory representatives.
Essential Skills
- Bachelor of Science in Engineering or related subject with 3-5 years' experience in a quality or technical discipline.
- Proficiency in ISO standards, Design Transfer, Manufacturing, Risk Management, NPI, PFMEA, and Validation.
- Strong understanding and application of procedures and concepts in the relevant discipline.
- Experience in CQA, CTQ, ISO14971, MSA, and PFMEA.
Additional Skills & Qualifications
- Good experience overhauling production (redo MVPs, redo PFMEAs, redo value stream maps, align procedures).
- Experience in quality engineering, medical device validation, design control, and product transfer.