Principal Quality Engineer

4 weeks ago

Irvine, United States Meet Full time

Primary Job Responsibilities / Skills

  • Lead quality engineering initiatives to meet organizational goals.
  • Offer guidance and direction in the formulation and assessment of validation policies, schedules, and protocols, as well as quality engineering matters. Demonstrate effective leadership or collaboration within quality-related decisions and practices.
  • Assist in enhancing process quality and testing procedures within the engineering department.
  • Provide technical proficiency in risk documentation processes.
  • Lead or participate in investigations concerning manufacturing non-conformities, product/component failures, customer complaints, or product returns. Conduct technical troubleshooting, FMEA, hazard analysis, root cause determination, and recommend CAPA solutions.
  • Contribute to non-conformance investigations, responses, and corrective action plans as necessary.
  • Provide direction and expertise in statistical methodologies, risk analyses, and other quality engineering tools.
  • Support supplier qualification efforts and collaborate with relevant departments on SCRs.
  • Lead design process characterization studies (DOE, R&R); analyze results statistically to identify critical parameters and enhance process capability.
  • Participate in Design Control New Product development teams. Offer guidance on design control requirements and review and approve related quality engineering and validation deliverables.
  • Perform other duties as assigned.


Requirements

Education & Training:

  • Bachelor's degree in Engineering or related sciences preferred.
  • Advanced degree is advantageous.
  • Certified Quality Engineer (CQE) or equivalent certification preferred.


Experience:

  • Minimum of five years' experience in validation and/or quality engineering within the medical device industry, including practical application of FDA Quality System Regulation and ISO 13485, or equivalent combination of education/experience.
  • Prior experience with class II or III medical devices
  • Understanding of manufacturing processes such as injection molding, assembly, packaging, and sterilization is essential.
  • Knowledge of international/ISO standards in ophthalmology is advantageous.
  • Familiarity with regulatory/compliance/validation matters is required. Candidates should be self-motivated, intelligent, and dependable.


Skills:

  • Excellent project management, organization, writing, communication, and presentation skills are essential.
  • Ability to communicate effectively across various styles and influence consensus among cross-functional groups.
  • Proficiency in technical writing, especially compliance and/or Validation/quality assurance documents and protocols, is necessary.
  • Familiarity with basic quality tools for formatting, trending, and presenting information (e.g., scatter plots, histograms, Pareto diagrams, flow charts, SPC, FMEA, Fault Tree Analysis) is required.
  • Proficiency in compiling, analyzing, graphing, and comparing data using standard statistical techniques (e.g., t-tests, ANOVA, linear regression analysis) is essential.
  • Demonstrated expertise in Windows-based software, including Word, Excel, Access, Project, and PowerPoint.
  • Proficiency in written and spoken English is required.

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