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TOMZ Corporation is looking for a highly motivated Quality Engineer to join our team in Berlin, CT!!
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.
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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.Â
- 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.Â
- Implement inspection plans for Incoming, In-Process and Final Product.Â
- Develop and justify appropriate sampling plans with characterization of test and inspection methods.
- Represent Quality Engineering in design reviews.Â
- 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.Â
- Support the development of Quality Agreements for external customers.Â
- 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.Â
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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.
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