Quality Assurance/Document Control Associate

Summary 

Responsible for assisting with technical and commercial documents for the company; maintain the flow of both electronic and hard-copied controlled documents, files, and resource materials. Maintains and updates computerized document/records system and ERP system (company-wide electronic information system) with critical information used throughout all facets of Production operations. Maintains confidentiality as this position works with intellectual and proprietary company information, both internal and external to the organization.

Essential Duties and 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.

Qualifications

• 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). *Biology, Chemistry, Biotechnology, Physiology, Microbiology, Histology
• Preferred experience in SAP and EQMS Software Solutions.
• 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.
• 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.).
• Working knowledge of medical device and IVD quality regulations.