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Quality Control Manager

5 months ago

Berlin, United States Tomz Corporation Full time
Job DescriptionJob Description

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, has been family owned and operated since the organization was founded in 1988. 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 internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback, this will promote and strengthen relationships within the organization and customer satisfaction.

ESSENTIAL FUNCTIONS:

  • Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
  • Plans, directs, monitors, maintain, support and coordinate all of the activities in the Quality department.
  • Manage flow of jobs going through the Quality department and coordinate scheduling priorities, and the need for inspection personnel.
  • 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.
  • Completes and compiles necessary documentation related to Quality Inspection standards.
  • 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.
  • Generate Packing Slips and Certificates of Compliance (C of C) in accordance with TOMZ and/or customer requirements.
  • Approve or reject parts, components, assembly processes and finish products based on compliance and quality benchmarks.
  • Collaborate with team members to achieve company, business unit and team goals.
  • 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.
  • Support physical and/or electronic record retention. Supervise use and maintenance of inspection equipment.
  • 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 in company and quality meetings.

QUALIFICATIONS:

Education/Experience:

  • Bachelor of Science in Engineering or another related field preferred or 5 years of directly transferrable work equivalency.
  • ASQ-CQT certification preferred.
  • 7+ years’ experience in a supervisorial/leadership role and 5+ years of Metrology experience

Additional Qualifications

  • Knowledge of GD&T and ISO13485 regulations.
  • Ability to automatically pivot in a fast-paced work environment.
  • Microsoft Office, Visio, and Minitab are preferred.
  • Strong communication and interpersonal skills.

Physical Demands

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 frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 25 pounds while moving tooling, fixtures, equipment and/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.


6-4:30 pm
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