Location: Sheboygan,WI, USA
POSITION SUMMARY:
Provide Quality Assurance support for production, purchasing, product development, project managers, and customers. Assist various groups to interpret and ensure product regulations and customer requirements are met. Quality Technicians review test data results, CoAs, and production records for both raw material and finished product releases. Duties may also involve working directly with the customer's Quality Assurance group or internal product development teams. Compose investigation reports to be submitted to the Quality Assurance Manager for approval of product disposition. Investigation reports are investigated by the technician to gather factual information to provide a bracketing rationale. Technicians are also relied upon for writing procedures and work instructions. Technicians may also be relied upon to provide information to the Quality Operations Manager or QA Manager to assist in quality decisions.
FLSA Status: Non-exempt
Grade Range: 7
ESSENTIAL ACCOUNTABILITIES:
* Device History Record and test data review and release of Finished Goods.
* Provide daily support to all manufacturing cells and other internal customers for Quality related issues and concerns.
* Non-conforming material investigations. Write investigation reports. Update NCM raw materials and finished product disposition.
* Customer support via emails, conference calls and production line tours.
* Work on special projects as assigned by the QA Manager or QA Supervisor.
* Training and development of production floor associates in the area of quality, procedures, and production records.
* Provide data as needed on request for Quality and Operational issues.
* Provide external customers with required finished good samples.
* Provide external customers with Certificates of Analysis or Certificates of Manufacture for products produced by Rockline.
* Demonstrate commitment to Rockline/Iatric's RRITE Values of Renew, Respect, Integrity, Teamwork, and Excellence.
* Associates have a direct and important role in ensuring that all work is performed in a safe manner. Effectiveness in carrying out this responsibility is part of each associate's essential accountabilities.
* Contribute to a cooperative working effort by demonstrating a willingness to perform other job-related work, as needed, or requested.
QUALIFICATION REQUIREMENTS:
* 0 to 3 years of related experienced required.
* Strong Microsoft Office skills required.
* Associates degree in related field a plus.
* Previous audit experience a plus
* Working knowledge of FDA regulations from 21 CFR a plus
* Experience with document control - report writing and creating procedures a plus
* ASQ certificate a plus.
SHIFT:
* Rotating Day Shift: 5:30AM - 5:30PM
* Week 1: Mon, Tues, Fri, Sat, Sun
* Week 2: Wed, Thurs
WORK ENVIRONMENT:
* 80% Inside work
* 18% Noise
* 2% Travel
Are you looking to join a recognized local employer, earn above average wages with a set schedule, and enjoy a clean work environment? Then Rockline Industries in Sheboygan is the place for you. Rockline maintains it's focus on recruiting and retaining associates that embody their values and take pride in their work. It's no wonder with associates like this that Rockline was voted Manufacturer of the year in 2014 and 2018. Join a company that fosters a culture of integrity, service and personal growth. One that values respect and continuous improvement.