Quality Engineer, Design Assurance

Position Summary

Principal Responsibilities

• Partner with R&D, Marketing, Regulatory Affairs, and Operations to support Value Engineering projects in product and process design such as design verification, design validation, design reviews, design transfer, and all other aspects of a design history file.
• Create and maintain risk files consisting of, but not limited to, risk management plans, hazard and risk analyses, failure mode and effects analyses, and risk management reports to assess the risks associated with a product impacted by the Value Engineering Project.
• Analyze post-market surveillance data periodically throughout a product’s lifecycle to update the risk file and reflect its current risk profile. Support Clinical and Medical Writers in analyzing available clinical data, as required.
• Use appropriate quality tools and statistical techniques to collect and summarize data, draw conclusions with confidence, determine sample sizes, apply data distributions, identify relationships between variables, calculate reliability, design and analyze experiments, determine process and performance capability, and make statistically supported decisions.
• Apply the most relevant and useful quality philosophies throughout Design Control and its related processes for both new product development and sustaining. Understand and manage work to minimize cost of quality throughout the product lifecycle.
• Ensure compliance with all practices related to the Quality Management System. Ensure comprehensive documentation is available, adequate records are produced, and change management is implemented.
• Interpret customer feedback to define user needs and product requirements as part of a cross-functional team.
• Understand applicable external regulations and internal standards that drive compliance and apply them in daily function.
• Partner with Usability Engineering SMEs and R&D to assess usability engineering requirements of product and packaging throughout design and development.
• Participate in the review and approvals of biocompatibility and clinical evaluation plans/reports.
• Perform gap assessments on relevant standards/regulations when necessary.
• Execute assigned projects, perform design assurance-related verification testing, and report if required.
• Partner with R&D to review and approve material assessment documentation related to Value Engineering Projects.
• Partner with R&D to review impact test methods for Value Engineering Projects and advise on suitable test methods to be conducted accordingly.
• Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
• Define, identify, and apply product and process control methods such as developing control plans, identifying essential design outputs and critical control points, and developing and validating work instructions.
• Apply concepts of producer and consumer risk and related terms, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc. Interpret and select variable, attribute, and zero-defect sampling plans.
• Apply supplier management principles and provide input on projects for supplier selection, quality expectation letters, supplier quality agreements, and process qualifications.

Education / Experience Requirements

• Degree or Diploma in Engineering, Science or Math, Degree in Chemistry, Polymer Science, Statistics and Certificate in Quality Engineering.•Two to three years’ experience in related field
• The candidate has an engineering background in Medical Technology, Packaging, plastic or chemical engineering.
• Must possess good technical writing ability including proficiency in Word, Excel, PowerPoint and QC tools
• Should have up to date knowledge on the validation requirements, ISO, standards, procedures and good knowledge in medical device requirements
• Excellent written and verbal communication skills
• Self-motivated and drive for excellent with good interpersonal skills for working across multifunctional teams
• Ability to articulate issues related to validation and manage multiple priorities with least supervision

Specialized Skills / Other Requirements