Lubrizol Quality Coordinator/Document Control in Victor, Montana
Quality Coordinator/Document Control
Vesta, a Lubrizol Company, creates custom medical manufacturing devices through silicone fabrication from its ISO 13485 certified facilities. Our products consist of silicone tissue expanders, sheeting, patches, and other silicone medical devices. Vesta takes pride in the quality of our products and maintains quality staff on our team.
In the Victor, Montana location, we have several ISO 7 and ISO 8 certified clean rooms within our campus. Our controlled environment allow for multiple line operations to occur efficiently without compromising on quality.
Seeking a Quality Assurance or Quality Control minded individual to fill the Document Control and Training Administrator (DCTA). The DCTA is primarily responsible for managing the records and documentation of our products and quality systems. Specifically, the DCTA is the process owner for Document control and Training. As the process owner, the DCTA is responsible for all documentation generated and all documentation changes and records generated as part of the Quality System. In addition, the DCTA is responsible for maintaining all employee Training Files/Records.
DESCRIPTION OF ESSENTIAL DUTIES:
Issue Document Change Notification (DACN) numbers.
Review all DACN files.
Process all DACN requests.
Maintain/Create (distribute and expire/obsolete documents) Quality controlled Documentation Binders.
Maintain Product and Customer Files.
Issue Part Numbers and Document Numbers.
Maintain Master documentation indexes.
Manage all Approved Documents electronic copies.
Archive old records (electronic and paper).
Update Quality System Records.
Issue Work Order Routers.
Check in, review and file Work Order Routers.
Maintain Work Order router Logbooks.
Create and Manage Training Files/Records for all employees
Provide training as required.
Manage late training completion.
Establish and maintain Training Metrics.
Maintain Outside Testing Logbook.
Create and Maintain Certification Books.
Other duties as assigned.
DESCRIPTION OF MARGINAL DUTIES:
Observe and promote Company standards and policies on safety, quality and productivity.
Understand current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in medical device and clean room environment.
Follow company rules as set forth in the Employee Policy handbook.
Demonstrate flexibility and cooperative behavior with colleagues and supervisors at all times.
HIRING GUIDELINES : (To perform job successfully, and individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required/preferred).
Successful completion of four-years of high school, or equivalent.
Six months minimum of experience, or any combination of education and experience that provides equivalent knowledge, skills and abilities.
Proficient computer knowledge, including Office products.
Demonstrated excellent (written and verbal) communication and effective human interaction skills.
Is flexible to change, possess a high degree of integrity, and operates with a “can do attitude”.
Willing to work in a team environment and contribute to group goals.
Has the ability to receive and provide instructions with a positive manner.
Ability to perform basic math calculations (add, subtract, multiply, divide).
SiMatrix is located in the heart of the Bitterroot Valley of Western Montana, within Ravalli County. Surrounded by the Bitterroot and Sapphire mountain ranges, the Valley provides scenic views and immediate access to the Anaconda-Pintler and Selway-Bitterroot wilderness areas. Our location allows for almost immediate access to the Clark Fork and Bitterroot Rivers, hiking, fishing, camping, rock climbing, hunting, snowmobiling, and skiing at Lost Trail Pass or Snowbowl Resorts. SiMatrix has two locations within the Bitterroot Valley. Our primary location is just south of Victor and the second site is located in Hamilton, Montana.
Lubrizol is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to sex, race, color, national origin, citizenship, age, religion, marital status, military service, sexual orientation, genetic information, gender identity, or any other characteristic or trait protected by federal, state, or local law.
Nearest Major Market: Missoula
Nearest Secondary Market: Montana
Job Segment: Document Control, Fabrication, QA, QC, Administrative, Quality, Manufacturing