ELITechGroup - A Bruker Company · 1 week ago
Quality Assurance/Document Control Associate
Logan,UT,US
Full-time
Onsite
Entry Level
2+ years expELITechGroup, a Bruker Company, is seeking a Quality Assurance/Document Control Associate responsible for managing technical and commercial documents. The role involves maintaining document flow, ensuring compliance with regulatory procedures, and supporting product notifications and recalls.
BiotechnologyHealth CareInformation TechnologyLogisticsManufacturingMedical
Responsibilities
Generates/manages Change Orders (CO) for technical documentation used in a medical device manufacturing operation; secures signatures and approvals on CO's
Maintains computerized system to electronically store, retrieve, update, and distribute engineering and manufacturing documentation
Assists in the development of all types of company documentation and resolving document control issues
Enters bills of materials and modifies BOM's as required by IS or Engineering changes
Support product notifications and/or product recalls; ensuring regulatory procedures and changes are implemented and followed
Performs document reviews and archiving of product build configuration records including; Operations Traveler, BOM, and "As-Built" (Lot History Record), as well as, QA inspection/test records
Maintaining records and ensuring accuracy of documentation; scan, image, organize and maintain documents, adhering to record retention policies
Ensures timely and accurate revisions to and distributions of pending and approved company documentation relating to policies, procedures, processes and products
Engaging internal and external customers as required to execute data management functions
Fulfills labeling requests for production work orders and finished product quality certificates
Participates in internal quality audits and supports facility audits conducted by customers and regulatory agencies
Qualification
Required
High School graduate, Life Science Associates degree preferred plus two years document control related experience in manufacturing industry (or equivalent combination in skills and education)
Must be a self-starter with strong interpersonal skills and ability to work with others in a positive and collaborative manner
Good knowledge and skills in the use of advanced personal computer productivity programs for word processing, spreadsheets, data base manipulation, presentations and flow charts; including imaging software (Adobe Acrobat)
Demonstrate effective planning and organizational skills, with the ability to work with a high degree of accuracy and recall
Ability to follow instructions/schedules/timelines and handle multiple priorities in a dynamic environment
Working knowledge of medical device and IVD quality regulations
Preferred
Preferred experience in SAP and EQMS Software Solutions
Preferred experience with reading and understanding technical drawings and specifications; and symbolism used in high-tech manufacturing (i.e., geometric dimensioning, formulas, scientific equations, graphs, etc.)
Company
ELITechGroup - A Bruker Company
ELITechGroup is a global leader in in-vitro diagnostics, serving hospitals and diagnostic laboratories in over 100 countries.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2023-12-27Acquired
2010-01-01Private Equity
Recent News
acnnewswire.com
2025-09-26
2025-07-08
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