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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Senior 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 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:
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.
- Corrective/Preventive Actions (CAPA):
- Responsible for CAPA system administration, tracking individual CAPAs, and, as necessary, performing work on and leading individual CAPAs.
- Complaints Investigation/Returned Materials Analysis:
- Knowledge of process(es) for investigation/analysis of returned/complaint materials.
- Nonconforming Material (NCM) Control:
- Knowledge of ID, traceability, containment requirements, Material Review Board (MRB) responsibilities and handling of NCM.
- Generate Gage Non-conformance documentation and execute containment, root cause and corrective action activities.
- Supplier Quality Management:
- Lead Qualification activities and maintenance of the Approved Supplier List (ASL).
- Lead management of Supplier/vendor Corrective Actions (SCAR).
- Internal Auditing:
- Lead efforts 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.
- Documentation Control:
- Support local Document Control (PLM) and Enterprise Resource Planning (ERP) systems.
- Preventive Maintenance, Calibration & Metrology (Gage R&R):
- Provide direction in the selection and testing methodology for defining and collecting data to support accuracy, reliability, and capability of measurement and test equipment.
- Generate protocols and execute Equipment Qualifications and Test Method Validations.
- Generate Quality Plans for the QMS and Organizational Objectives projects.
- Lead Quality Management System initiatives and continuous improvement activities.
- Provide input on and coordinate tracking/trending & reporting of quality system metrics.
- 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 4-6 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.