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.
• Additional responsibilities as outlined in full job description.

Qualifications:

Education

• Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).

Experience

• Minimum of 2-5 years’ experience in a regulated manufacturing environment.
• Experience in Class I, II, and/or III medical device manufacturing within a regulated environment (e.g., Aerospace, Defense, Pharmaceutical, etc.).

Qualifications

• Advanced Post-Secondary Education, Training or Certification coursework.
• Knowledge of statistical techniques to analyze process capability.
• Quality certification(s) (e.g., ASQ CQE, QCI, etc.).
• Skilled in First Article Inspections and Component Qualifications.
• Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).
• Experience in effectively supporting audits by customers and external regulatory agencies.
• Strong verbal and written English language communication skills.
• Successfully meet TOMZ-specific positional and functional on-the-job training requirements.
• Proficiency with Microsoft Office.
• A self-starter capable of working independently and as part of a team, with the ability to collaborate across various functional areas, including R&D, Manufacturing, and QA, to achieve results.