Quality Engineer

Job Description

Job Description

Job Title : Quality Engineer

Department : Quality

Reports To : Quality Engineering - Lead

FLSA Status : Exempt

Job Summary and Objectives :

The Quality Engineer will support the Quality Management System (QMS) to ensure compliance to FDA Quality System Regulation, ISO 13485 and other relevant Quality System Standards. The Quality Engineer will also participate in product development teams to provide design control quality assurance support to medical device development and validation efforts.

Essential Duties and Responsibilities :

• Understand and ensure compliance to ISO 13485, 21 CFR Part 820 and NextPhase Quality System requirements.
• Support audits performed by Notified Bodies and regulatory agencies as well as audits performed by customers.
• Perform / participate in audits of NextPhase suppliers as required.
• Act as the NextPhase quality interface for assigned customers and / or suppliers.
• Participate in the technical review of design input specifications and design documentation for new medical devices.
• Assist in the planning, development and execution of verification and validation protocols for testing of products under development.
• Conduct risk analysis for products under development and for active products as required by the customer.
• Create Quality Plans and Master Validation Plans in support of customer product implementation.
• Support existing product / process issues, including NCRs, MRB, root cause analysis, Deviations, customer complaints, failure investigations and corrective actions.
• Manage customer deliverables and quality documents to an approved / released state.
• Perform such other functions, responsibilities, tasks and / or projects that are reasonably related to the above essential job functions and responsibilities and / or as NextPhase Medical Devices LLC may from time-to-time assign to the employee.

Supervisory Responsibilities [if applicable] :

Required Qualifications and Work Experience :

Minimum Education and Experience :

Skills

Preferred Qualifications and Work Experience :

Education and Experience :

Additional Eligibility Qualifications :

Physical Demands :

Work Environment :

Additional Information :

Job Description is a Guideline Only :

Equal Employment Opportunity Statement :