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TOMZ Corporation, a leader in manufacturing devices and components for major medical device
companies, is looking for a Quality Engineer – Design & Development to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.
SUMMARY OF POSITION:
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.
- Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
- Author and execute Quality Plans for Quality Product Design and Development projects.
- Initiate and/or consult in the development and/or update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
- Establish severity and risk-based Process Master Validation Plan strategies with appropriate
- Support operational and process qualifications for customer manufacturing processes in
cooperation with cross-functional engineering teams per project requirements.
- Drive Test Method development (w/ Operational and Business considerations) and execute Test Method Validations to measure effectivity.
- Provide direction in implementing Incoming, In-Process, and Final Product Inspection plans.
- Develop and justify appropriate sampling plans with characterization of test/inspection methods.
- Champion First Article Inspections and Component Qualifications.
- Represent Quality Engineering in design reviews throughout the process development process.
- Support initial qualification audit activities (Customer and Regulatory Agencies).
- Assist in qualification activities associated with supplier/vendor design characterization
requirements for projects, to include audits and assessments.
- Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing,
communicating, and resolving quality issues.
- Ensure compliance of all site personnel to site-level QMS and training requirements.
- May support the development of Quality Agreements for external customers.
- Other duties and responsibilities as assigned.y
- Minimum 4-Year degree or equivalent of directly-transferrable industry work experience
(Engineering or Quality discipline preferred).
- Minimum of 2-5 years’ experience in a regulated manufacturing environment.
- Advanced Post-Secondary Education/Training/Certification coursework
- Quality certification(s) (e.g. ASQ CQE, QCI, etc.).
- Class I, II, and/or III Medical Device manufacturing experience.
- Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.).
- Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially 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/functional on-the-job training requirements.
- Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
- “Hands-on” self-starter with ability to work both independently and as part of a team.
- Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.