Job: Quality Assurance Technician Days

Jobing Description

Job Description

Accellent, Inc. is a fully integrated provider of design, supply chain management and strategic sourcing services to the Medical Device industry. Accellent www.accellent.com, a recognized market leader, is a fast-growing outsource manufacturing and design solution company specializing in high growth areas such as Cardiology, Endoscopy and Orthopaedics. The top Medical Device companies partner with Accellent to provide innovation, advanced technology, speed to market, low cost labor and strategic sourcing. With approximately 20 locations, Accellent employs more than 3,000 people in 6 countries.

Currently, we are searching for a Quality Assurance Technician (Days) to join our Quality Assurance Team at the Brooklyn Park, MN facility.

Position Scope / Summary

The Quality Assurance Technician 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.

Required Skills

Key Result Accountabilities

* Must be proficient in interpreting Engineering blueprints and drawings as well as all of the GD&T (Geometric Dimensioning and Tolerancing) callouts, especially the concepts of true position, concentricity and profile.
* Must be familiar with the use of inspection sampling plans, AQL and confidence level;
* Must be familiar with setting up and running a Gauge R&R, as well as capability studies;
* Experience using a stastistical package is helpful, especially MiniTab;
* Must know all inspection tools, such as micrometer, caliper, optical comparator, gauge blocks, dial indicators, surface plate;
* The ability to program a Vision machine, such as OGP smartscope with the measuremind software. The ability to write, debug and edit programs is a must. As well as the experience in working with lots of data and importing inspection data into other applications;
* Must be familiar with the Smartprofile software and the ability to set up new parts in order to evaluate their inspection results from different inspection equipment;
* The ability to run and program a Brown and sharp CMM with PC-DMIS is preferrable;
* Proficient use of MS office applications such as MS Word and Excel;
* Must be a good communicator in English, both written and spoken;
* Prefer experience with current Quality tools and concepts, including Lean / Six Sigma / ISO 9000 & AS9100. Must have a good understanding of ISO-9001; and
* The ability to work well with others individually and in a team setting, be a problem solver, exhibit a positive can do attitude, apply oneself to continually improve self and company process, work without close supervision, make 'on the spot' decisions, present verbal/written reports.

Required Experience

Qualifications

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Technical degree and 3 years equivalent experience in similar regulated field; Medical Device experience strongly preferred

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Laser inspection experience preferred

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Must be able to complete multiple prioritized tasks with minimal direct supervision, while maintaining focus on preventative activities

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Complete all job-specific required training

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Ability to understand and comply with the FDA s Quality Systems Regulations (QSR) and ISO 13485:2003 standards

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ASQ certification as a CMI, CCT, or CQT is required within one year of being in the position

Job Location
Brooklyn Park, MN US
Position Type
Full-Time/Regular

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