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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Document Control Specialist 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 Leadership and management of personnel and resources to ensure adherence and compliance to TOMZ's Quality Management System processes and policies with oversight for the Quality Inspection teams.
- This position will have direct-reporting responsibilities and/or supervisory responsibilities for daily activities of Supervisors, Inspectors, Contract Personnel and/or Quality Technicians.
- This position is responsible for the functional management of Receiving Inspection, In-process Inspection, and Final Product Inspection.
- Provide team leadership, coaching, mentoring and guidance to all Quality Control personnel, as well as cross-functional teams.
- Manage and evaluate Quality Control operational efficiency to support Production/Business needs.
- Drive continuous improvement efforts to enhance effectiveness and opportunities to streamline new and current inspection controls and test methods.
- Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
- Must be knowledgeable of, and adhere to, the TOMZ Quality Management System and its requirements.
- Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidelines and rules.
- Provide support for the compliance of Quality System support elements (QM 'feeder' systems) for the site QMS and the tracking & reporting of associated metrics, as required.
- Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
- Support site customer-requested auditing activities (Customer and Customer Regulatory Agencies).
- Ensure compliance of all site personnel to QMS and functional training requirements.
- Drive and support QMS initiatives and continuous improvement activities.
- Administration of employment practices, including, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees, and performed in compliance with Federal and local laws, as well as TOMZ policies.
- Other duties and responsibilities as assigned.
- Associate/Bachelor of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred)
- Minimum of 5 years Leadership/Supervisory-level experience, with budget and decision-making authority/responsibilities.
- Minimum of 5 years’ experience in a regulated manufacturing environment.
- Advanced Post-Secondary Education/Training/Certification coursework
- Quality certification(s) (e.g. ASQ CQT, 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 coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
- Strong verbal and written English language communication skills.
- 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.