TOMZ Corporation is looking to hire a highly motivated Quality Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Those include 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 is responsible for improving safety, quality, delivery, productivity, and cost by proactively improving the quality systems of the company. Through quality sciences, leading process improvement programs, and interaction with direct reports and key partners the Quality Manager will strive to continuously improve the process by leading a cross functional team of Quality Inspectors, Metrologists, Quality Engineer, and others to reduce risk, improve customer satisfaction and achieve quality at the source. The Quality Manager also manages the quality control function to ensure process compliance to the DMR and that medical devices are safe and effective.
Essential Functions
- Plans, directs, monitors, maintain, support and coordinate all of the activities in the Quality Control department.
- Creates and executes strategies to implement quality assurance and control at the source of process risk points.
- Manage flow of jobs going through the Quality Control department and coordinate scheduling priorities, and the need for inspection personnel.
- Manages the metrology team to build reliable, repeatable, and reproducible advance measurement techniques.
- Supports tiered management and helps the team resolve problems and escalates problems as appropriate.
- Provides guidance and mentoring to cross functional team to continuously strengthen the team to accomplish objectives and grow their careers.
- Controls the duties and performance of inspectors by providing training assistance for inspections on machined components, as required, utilizing conventional visual and layout inspection techniques and equipment- i.e: include microscopes, calipers, micrometers, and gages.
- Support Quality Best Practices and GDP/GMP continuous improvement efforts.
- Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
- Utilize the ERP system to prioritize and support product final acceptance and shipment, as needed.
- Approve or reject parts, components, assembly processes and finish products based on compliance and quality standards.
- Collaborate with team members to achieve company, business unit and team goal.
- Maintain appropriate staffing levels to include hiring, training, and employee performance.
- Proactively identify areas for improvement and implement plans to achieve and realize those improvements.
- Provide interpretation and manage external, internal, customer and supplier quality issues.
- Review, create, approve, and implement customer quality requirements including new projects, revision, or specification changes.
- Review and approve subcontractors’ quality documentation.
- Cooperate with department managers and customers.
- Participate and collaborate and support Quality Systems Audits.
- Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
- Other Duties as assigned.
Qualifications:
Education
- Bachelor of Science in Engineering or another related field preferred or 5 years of directly transferrable work equivalency.
- ASQ-CQT, CQE, CRE, or CQA certification preferred.
Experience
- 3-5 years’ experience in a supervisorial/leadership role.
- 5+ years of Metrology experience
Qualifications
- Knowledge of GD&T and ISO13485 regulations.
- Ability to automatically pivot in a fast-paced work environment.
- Demonstrated organizational and project management skills.
- Effective communication and interpersonal skills.
- Microsoft Office.
Preferred Skills
- Visio, and Minitab are preferred.
