Quality Engineer

Job Description

Summary of Position :

Reporting to the Quality Engineering Manager, this position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.

Essential Functions :

• Develop and execute Quality Plans for Quality Product Design and Development projects.
• Collaborate with engineering teams to initiate and support the development and updates of Risk Management documentation in accordance with project requirements.
• Establish severity and risk-based Process Master Validation Plan strategies with appropriate V&V rationales.
• Support operational and process qualifications for customer manufacturing processes in collaboration with engineering teams.
• Drive Test Method development with Operational and Business considerations and execution of Test Method Validations to measure effectiveness.
• Implement inspection plans for Incoming, In-Process and Final Product.
• Develop and justify appropriate sampling plans with characterization of test and inspection methods.
• Represent Quality Engineering in design reviews.
• Support initial qualification audit activities for Customer and Regulatory Agencies.
• Support qualification activities related to supplier and vendor design characterization requirements for projects, including conducting audits and assessments.
• Support Quality Best Practices and contribute to continuous improvement in GDP / GMP.
• Apply sound, systematic problem-solving methods in identifying, prioritizing, communicating, and resolving quality issues.
• Ensure that all site personnel comply with the site-level Quality Management System and training requirements.
• Support the development of Quality Agreements for external customers.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Qualifications :

Education :

Experience :

Physical Requirements :