Quality Engineer

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:

• 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.

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.).

Physical Requirements:

• Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.

• Ability to sit for prolonged periods.

• Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.

• Perform keyboard entries with frequent operation of a computer.