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TOMZ Corporation, a leader in manufacturing of 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 V&V rationales.
- 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 execution of 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.
- 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.
While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.