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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Quality Systems Engineer to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision, and paid time off. TOMZ maintains modern, clean, and safe facilities 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:
The position will be responsible for ensuring operational adherence and compliance to TOMZ’s Quality Management System (QMS) requirements. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.
- Preventive Maintenance, Calibration & Metrology (Gage R&R):
- Knowledge of selection and testing methodology to define and collect data to support accuracy, reliability, and capability for purpose of measurement and test equipment.
- Drive Equipment Assessment & Qualifications, Equivalency and Transfer Strategies, Software Validations and Test Method Validations
- Maintain, support and continuously improve internal and external calibration and preventative maintenance services
- Lead investigation and containment activities of Gauge Non-Conformance and Equipment/Environment out-of-specification conditions
- Maintain, monitor and ensure site compliance to facility infrastructure and work environment requirements
- Corrective/Preventive Actions (CAPA):
- Drive corrective action implementation, with a primary focus on Quality System elements.
- Complaints & Nonconforming Material Investigation:
- Knowledge of process(es) for investigation/analysis of nonconformances and identification of systemic improvements.
- Internal Auditing:
- Provide support for the system to ensure all internal audits are performed as scheduled.
- Assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality System, including investigation observations/findings and reporting.
- Support Quality Management System initiatives and continuous improvement activities.
- Support site customer-requested auditing activities (Customer and Regulatory Agencies).
- Ensure compliance of all site personnel to QMS requirements.
- Ensure adherence to training requirements regarding Quality Management System elements, controls, processes and procedures.
- 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.