Advanced Quality Engineer Job Description

Advanced Quality Engineer Job Description Template

Our company is looking for a Advanced Quality Engineer to join our team.

Responsibilities:

  • Participate in collection of initial market feedback on new products and address early concerns;
  • Evaluate predicate products for relevant quality issues tthat may impact new product development projects;
  • Develop, review, and approve inspection plans, routers, and product drawings for new products;
  • Lead investigation and health risk assessment for post-market events;
  • Analyze and define critical quality attributes for product and process through risk analysis techniques;
  • Engage in the design, development, manufacturing, and risk management activities for new product development projects;
  • Support product design transfers to internal and/or external manufacturing facilities;
  • Support quality system maintenance for the design control process by identifying and correcting deficiencies in procedures and practices;
  • Develop quality assurance documentation to support new product development process and regulatory submissions.

Requirements:

  • Strong analytical problem solving and decision making skills;
  • Experience with LEAN Six Sigma methodology and use of quality/statistical tools;
  • Bachelor’s degree in a Science, Technology, Engineering or Mathematics (STEM) discipline from an accredited institution;
  • Ability to lead and be a contributing member of cross functional teams;
  • Bachelor’s degree or higher (completed and verified prior to start) from an accredited institution;
  • American Society for Quality (ASQ) certification such as Quality Engineer (CQE) or willingness to obtain;
  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required;
  • Strong in critical thinking and “outside the box” thinking;
  • Demonstrated ability to successfully manage and complete projects in a matrix organization;
  • Demonstrated ability to advocate for product excellence and quality;
  • Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation;
  • Thorough knowledge and understanding of US and International Medical Device Regulations;
  • Highly developed problem-solving skills. Strong analytical skills;
  • Experience in working in a compliance risk situation;
  • Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).