shipments for damage, verifies the quantity of items delivered match the quantity of items ordered. Processes incoming items properly and received items into the company ERP. Inspects items according to pre-established inspection criteria and sampling plans.
Maintains records of all inspections. Verifies the status and maintains records of all inspection, measuring, and test equipment used during inspection. Processes RMAs and other returned goods according to established process. Quality Control and Final Inspection Inspects printed labels for proper variable information (Lot Number, Expiration Date, etc) and accuracy, as well as other second party verification activities. May contribute
to Final Product QC, Document Control activities, and other Quality Assurance/Quality Control activities, as required. Other Utilizes a variety of test equipment including: pin gauges, calipers, micrometers, height gauges, color charts, volt meters, spectrophotometers, p H meters, and many more.
Quarantine products that do not conform to specification and processes the products according to the Control of Nonconforming Product Process. Assists with related special projects, as required. Qualifications High school diploma or general education degree (GED); or one to three months related experience and/or training; orequivalentcombinationofeducationandexperience. Fork-lift experience is a plus. Job Posted by Applicant Pro
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 Project Coordination and Management of Quality Assurance projects across multiple departments and functions. Supports the maintenance of the overall Document Control System - Generates/manages Change Orders (CO) for technical documentation used in a medical device manufacturing operation; secures signatures
and approvals on CO's. Train and mentor users of the system to ensure success. Maintains and implements computerized systems 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 (BOMs) and modifies BOMs 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. Maintains records and ensures accuracy of documentation (in accordance with Good Documentation Practices); 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. Engages 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 four years medical device related experience (or equivalent combination in skills and education). Biology, Chemistry, Bio technology, Physiology, Microbiology, Histology 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. Job Posted by Applicant Pro
