Principal Engineer - Quality
Irvine, CA
Schedule:
8 AM - 5 PM
Duration:
9-Month Contract
Pay:$58-63/hr (W2)
Our client is a leading global medical technology company specializing in critical care innovations. They are seeking a Quality Engineer to join their Quality Engineering team, working closely with R&D and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients' lives around the world.
Essential Functions and Responsibilities
- Identify and solve complex problems in a multi-stakeholder, team setting where precedent may not exist, using creativity while maintaining compliance with industry regulations
- Manage cross-functional projects, timelines, and budgets; implement digital quality tools (eQMS, dashboards)
- Translate technical information to all levels of the organization through large and small presentations
- Independently lead QMS improvement activities and associated projects
- Own and perform documentation changes and set policies and standards that are followed by others
- Lead CAPA execution, root cause investigations, and quality data analysis to identify trends
- Own and drive validation testing (all types), TMV, and software validation testing
- Lead identification, development, and optimization of complex manufacturing processes using engineering methods (e.g., Six Sigma and Lean tools) for design for manufacturing and continuous process improvement
- Identify opportunities and implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc., to improve manufacturing processes and reduce risk
- Drive development and manage execution of complex experiments and tests (including writing and executing protocols) to validate and improve products and establish robust manufacturing processes; ensure completion of process validations (IQ/OQ/PQ), analyze results, and develop reports
- Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
Education and Experience
- Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Biomedical, Bioengineering, or other applied sciences)
- 6 years of experience in medical device engineering or medical device quality roles
- Travel required ~15%
Knowledge and Skills
- Statistical based software (Minitab, JMP)
- Certified Quality Engineer (CQE) or equivalent
- Measurement and Test Equipment knowledge and experience
- Process Validation experience
- Comprehensive expertise in Quality Engineering principles and applications (CQE body of knowledge)
- Proficiency in quality tools (FMEA, CAPA, statistical analysis)
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