Technician Quality Assurance 2

POSITION SCOPE/SUMMARY

This position is necessary to provide accurate and timely movement of product through the facility. The ability to verify correct and legible marking on product, support quality with basic inspection, and ensure proper and timely shipments to our Customers is required.

POSITION REQUIREMENTS

  • Calibration Support
    • Assist with maintenance of systems that monitor the accuracy of all measurement and test equipment
    • Assist with calibration as required for all company owned equipment as well as personal tools.
    • Assist with the repair of gages as needed; if unable to do internally, send to an outside repair service and /or request a replacement
  • Manufacturing Support
    • In process inspection as required
    • Inspect vendor supplied components / assemblies. Assist suppliers in duplicating our inspection techniques and meeting our product specifications
    • Laser inspection (First piece Laser certification)
    • Inspect vendor work with the Smartscope V.M.M.
    • Use all gaging methods in the facility, including roundness checker, profilometer, and height stands
    • Develop expertise in GD&T and other blueprint and dimensioning methods
    • Train associates on laser inspection and assist in obtaining certification
  • Final Product Release
    • Assist with documentation of any discrepancies as appropriate  Control of Non-Conforming material/ parts are Quarantined to prevent shipment
    • Certify documentation (i.e.: Certification, first article data, process capability study, etc.) prior to shipment
    • Verify packaging matches specified requirements (where indicated) or is adequate if no specific requirements exist
    • Verify customer purchase order requirements
    • Verify /sign completed shipment verification review form
  • Continuous Improvement
    • Comply with work rules including safety, health, quality system, and Viant Medical Quality Management Systems
    • Assist in investigating and preventing customer complaints
    • Work with customers and suppliers to implement corrective and preventive actions
    • Participate in Internal Quality Audits, following Internal Audit training
    • When asked, serve as a member of Continuous Improvement teams

ENVIRONMENTAL WORKING CONDITIONS

  • Employee must comply with all safety policies and safe work procedures established by the company.  Job tasks may also involve:
    • Using personal protective equipment such as safety glasses, goggles, gloves, and other equipment as established in company policies and safe work procedures
    • Working near cutting & machining fluids, solvents, lubricants and other hazardous chemicals using appropriate safety controls
    • Lifting up to 50 pounds
    • Frequent carrying, bending, standing, sitting, and repetitive motion
  • Employee will be expected to attend safety training, serve on the facility safety committee, if asked, and participate in hazard analysis and resolution.

QUALIFICATIONS

  • Technical degree and 3 years equivalent experience in similar regulated field; Medical Device experience strongly preferred
  • Laser inspection experience preferred
  • Experience with MS-Word, Excel, Access, and PowerPoint for word processing and documentation support
  • Good teamwork and communication skills to facilitate training and group problem solving
  • Must be able to complete multiple prioritized tasks with minimal direct supervision, while maintaining focus on preventative activities
  • Complete all job-specific required training
  • Ability to understand and comply with the FDA’s Quality Systems Regulations (QSR) and ISO 13485:2003 standards
  • ASQ certification as a CMI, CCT, or CQT is required within one year of being in the position

It is impossible to list every requirement for, or responsibility of, any position.  Similarly we cannot identify all the skills a position may require since job responsibilities and the Company’s needs may change over time.  Therefore, the above job description is not comprehensive or exhaustive.   The Company reserves the right to adjust, add to or eliminate any aspect of the above description.  The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.

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ABOUT VIANT

At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.