Calibration Technician - Berlin, United States - Tomz Corporation

Description

Job Description

Calibration Technician

Quality

Reports to: Quality Control Manager

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Calibration Technician 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 have direct responsibility for the quality control functions as well as gage crib responsibilities within the Department. TOMZ manufactures parts via high precision metal machining, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation.

ESSENTIAL FUNCTIONS:

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Maintenance of the Calibration System to ensure that all inspection, measurement and test equipment, including mechanical, automated, electronic inspection and test equipment, is capable of producing accurate and valid results.
• Handle all TOMZ calibration functions including;
  1. Coordinate on-site calibration of all gages at required frequencies.
  2. Send functional gages to various vendors /customers.
  3. Quote and source gages/equipment to aid Inspection and Manufacturing
  4. Review certificates for low limit conditions, perform containment and aid investigation of "As Found" conditions close to or exceeding manufacturer recommended tolerances.
• Schedule maintenance and repair for all measuring equipment through-out the shop.
• Perform periodic audits of the calibration and maintenance systems to ensure compliance, control and accurate reporting of inspection/test equipment.
• Receive and ensure proper control and reconciliation of product labels.
• Support incoming, First Piece, FAI, In-process, and Final Inspection with calibrated gages.
• Creates, completes, and compiles necessary documentation related to Quality Inspection standards.
• Support other Quality Department functions, as needed.
• Identify, segregate and control of non-conforming equipment and or gages.
• Other duties and responsibilities as assigned.

QUALIFICATIONS:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).

Experience

• Minimum of 2 years' experience in a regulated manufacturing environment.

Qualifications

• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge of and experience with GMP/ISO standards.
• Strong background concerning the usage and care of mechanical measurement equipment, tools and hand-held tools including micrometers, calipers, dial indicators, height gages, pin gages, etc.
• Ability to effectively read and understand blueprints, specifications and procedures.
• Always maintains accuracy and attention to detail and completes tasks in a timely manner.
• Knowledge of dimensional, visual, and mechanical inspection processes
• 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 as required accomplishing results with minimal guidance.
• Understands the proper operation of and capability of CMM equipment is a plus.

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 occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 20 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.