Quality Technician

Job Description

Job Description

Summary :

Support Quality Management System activities not limited to performing, component first article

and receiving inspection activities, in-process and final inspection activities of assemblies,

manage training system activities according to company Standard Operating Procedures (SOP)

document management system activities. Perform duties to support established procedure and

quality guidelines. Work with cross-functional sustaining teams to ensure safety, quality and

compliance of products.

Essential Duties and Responsibilities :

Lead in-process and final testing efforts to satisfy pre and post market product

requirements.

Perform dimensional inspections using laser micrometers, vision systems, mandrels,

go / no- go fixtures, rulers, indicators, calipers and micrometers.

Manage and review assembly records to ensure proper : kitting materials, training status

of assemblers, equipment and calibration, documentation practices, etc.

Initiate Non-Conforming Material Requests as necessary, work with team to determine

appropriate actions and dispositions.

Execute tasks that assist in identifying, communicating, and resolving quality issues.

Maintain component identity by following established documentation and traceability

processes.

Follow established safety procedures and perform duties in a safe manner.

Identify and diagnose problems and follow through to resolution.

Participate as a team member by assisting others and by receiving and giving day to day

feedback to ensure the achievement of quality results.

Perform other tasks as assigned or as required to function as member of a work team.

Perform all duties of this position in accordance with FDA and ISO 13485 standards.

Technical Skills :

Highly proficient with MS Office (Word, Excel, Access), Adobe Acrobat, internet and e-

mail systems. Solid understanding of software capabilities and business applications

associated with Grand Avenue Software.

Understanding of Quality System Documentation.

Ability to learn and apply good manufacturing practices (GMP's) and inspection

processes as well as ISO 13485 and FDA requirements.

Must be able to use sampling plans.

Use and be familiar with measuring tools functionality and accuracy requirements.

Ability to read and comprehend component / material drawings / prints.

Knowledge of basic manufacturing concepts and workflow preferred.

Ability to perform basic math operations including addition, subtraction, multiplication

and division, as well as knowledge of basic geometry.

Education / Experience :

High School diploma or equivalent, with 4+ years’ relevant experience.

2 year college degree preferred.

Minimum of two years’ experience with quality system documentation and electronic

systems.

Experience in medical device inspection required.