Principal Quality Engineer

General Purpose Summary

This position is primarily responsible for leading and assisting with BD/Supplier cross-functional discussions, evaluation and qualification of new supplier capability, and formalization of agreed terms within the Supplier Quality Agreement (SQA) to support EU MDR or other business initiatives, as needed.

Essential Job Functions

• Lead and support the EU MDR team in discussions with suppliers to obtain necessary arrangements for kit component compliance.
• Support EU MDR team in kit component supplier selection, assessment, and management.
• Formalize details of supplier arrangement in Supplier Quality Agreements and coordinate necessary approvals.
• Provide technical direction during supplier selection/development when new suppliers are selected.
• Work with cross-functional team to address supplier issues, develop new suppliers and qualify new kit components.
• Manage supplier compliance to company and industry requirements.
• Understand and follow company procedures on regulatory requirements.
• Help facilitate revisions to SQA template to address EU MDR requirements, as needed.
• General supplier management (including, but not limited to: developing suppliers, addressing supplier issues, developing documentation, updating supplier documentation, internal agreements within BD)

Basic Skills/Competencies Required

• CAPA experience (including Root Cause Analysis, Corrective Action, Preventive Action, Effectiveness Verification) - critical
• Manufacturing experience – critical
  • Ability to analyze manufacturing and quality systems and provide recommendations for improvement
• Supplier management - critical
• Strong written and oral communication skills - critical
• Strong interpersonal skills - critical
• Working knowledge of EU Medical Device Regulation, FDA Regulations, GMP/GLP, and ISO.
• Ability to make and present engineering decisions
• Strong organizational skills
• Ability to work independently
• Comparative statistics
• Knowledge of Design of Experiments
• Knowledge Statistical Process Control
• Audit experience preferred
• Oral and written presentation skills
• Must read, write, and understand English. Must be detailed in handling information/data.

Education Requirement

A minimum of a Bachelor’s degree in a technical field.

Experience Required

• 5 years experience in medical devices – critical
• 10+ years experience in medical device - preferred