Principal Quality Engineer

Job Description :

Pay Range: $60.01hr - $63.34hr

Requirement/Must Have:

• Bachelor s or Master s degree in Engineering (Mechanical, Chemical, Biomedical, Bioengineering, or related applied sciences).
• Experience in medical device engineering or medical device quality roles.
• Experience with statistical software such as Minitab or JMP.

• Minimum 6 years of experience in medical device engineering or quality engineering.

• Identify and solve complex problems in cross-functional environments while maintaining regulatory compliance.
• Manage cross-functional projects, timelines, and budgets.
• Implement digital quality tools including eQMS and dashboards.
• Translate technical information through presentations to all organizational levels.
• Independently lead QMS improvement activities and related projects.
• Own documentation changes and establish policies and standards.
• Lead CAPA execution, root cause investigations, and quality data analysis.
• Drive validation testing, TMV, and software validation activities.
• Lead manufacturing process development and optimization using Six Sigma and Lean tools.
• Identify and implement equipment, automation, and process improvements to reduce risk.
• Develop and execute complex experiments and validation protocols.
• Ensure completion of process validations (IQ/OQ/PQ), analyze results, and prepare reports.

• Certified Quality Engineer (CQE) or equivalent.
• Process validation experience.
• Measurement and test equipment knowledge.
• Experience investigating manufacturing quality and compliance issues.

• Quality tools including FMEA, CAPA, and statistical analysis.
• Strong analytical and problem-solving abilities.
• Excellent communication and presentation skills.
• Ability to manage complex projects independently.
• Expertise in Quality Engineering principles.

• Bachelor s or Master s degree in Engineering or related applied sciences.