Quality Engineer

The primary purpose of Quality Engineer III is to provide support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.

• Adheres to Client Core Values and all safety and quality requirements including, but not limited to:
  Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
• Participates in the development, completion, and maintenance of risk analyses.
• Leads the generation and completion of protocols and reports for product, process, and test method validations.
• Collaborates with Manufacturing Engineers to review processes for new and existing products and supports the coordinate of process validations and capability studies.
• Supports the development various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, implementation, and training of Incoming, In-Process, Manufacturing instructions, and Final Inspection procedures.

• Ability to read and write in English.
• Self-motivated with strong ability to adapt to change.
• Ability to work cross-functionally and as part of a project team.
• Ability to read and interpret technical drawings.
• Proficiency in statistical tools (e.g., Gage R&R, Capability Analysis, ANOVA);
  Minitab experience is a plus.
• Experience in ISO 13485 industry.
• Ability to conduct root cause investigations using techniques such as FMEA, Fishbone, 5 Why, and 8D.
• Knowledge of Process Validation (IQ, OQ, PQ, TMV).(Must)
• Detail-oriented with strong organizational skills.
• Experience in audit processes (internal or external audits).