Hardware Quality Engineer
Posted on 4/4/2023
quip designs and delivers oral care products, advice, and services.
New York, NY, USA
Experience Level
  • 5+ years of experience in quality engineering or related field such as Engineering or Manufacturing
  • Analytical curiosity and ability to solve complex problems using data
  • Experience completing quality deliverables during new product development and into production
  • Broad general mechanical and electrical engineering knowledge
  • Working knowledge of some or all: ISO 13485 and/or 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR), ISO 9001
  • Experience developing and implementing sampling plans, IQ/OQ/PQ, and process controls
  • Six Sigma/Lean certification preferred
  • Strong verbal and written communication skills, internal and external to the company
  • Good interpersonal skills in dealing with a global supplier chain, peers and other functional areas
  • Willing to travel domestically and internationally
  • Serve as the primary Quality contact point for both quality assurance and quality control for electronic and hardware product development through end of life
  • Prevent customer satisfaction and durability issues by coordinating Failure Mode Effects Analysis (FMEA's), product design specifications and tolerances reviews, past problem history, and supplier development
  • Establish and ensure conformance to engineering standards, product specifications, and highest customer expectations
  • Develop and release product/process control plans, inspection standards, quality and testing plans and instructions, visual work instructions, technical specifications, and various manufacturing validations
  • Contain defective products through ownership of problem definition (8D's), Root Cause Analysis (RCA's), dispositions review, tracking of resolution effectiveness, and Containment coordination
  • Detect non-conformances and process variations through use and standardization of SPC systems, Change Control management, and both Internal auditing and Layered Process auditing
  • Lead cross-functional problem solving teams to drive process and product improvements; use of QA methodologies to manage and facilitate issue resolution including root cause investigations and the development, implementation and monitoring of effective corrective and preventive actions
  • Track and improve performance to internal and external quality performance metrics
  • Conducts investigations and Root Cause Analysis derived from Customer Complaints, RMAs, CAPAs, Manufacturing Process Data, Product Teardowns, and Field Audits
  • Creates, edits and/or revises Test Method Validations, SOPs, WIs, and Product Specifications in support of continuous improvement
  • Accurately and thoroughly responds to customer requests for quality data or quality inquiries
  • Conducts employee training as required (i.e., GMP, Root Cause Analysis and best practices)
  • Supports company goals and objectives, policies and procedures, Good Manufacturing Practices, and applicable FDA, ISO, and other regulatory requirements. Acts as a Quality ambassador for the company to promote Quality culture
  • Onboards and manages suppliers to quality performance targets; tracking and trending supplier performance with scorecards
  • Support and monitor suppliers compliance to FDA requirements, ISO 13485, ISO 9001, etc
  • Provide input to the supplier selection process