BD (Tissuemed Ltd) · 2 days ago
QA Associate II
Mebane, NC
Full-time
Onsite
Entry Level
2+ years expBD is one of the largest global medical technology companies in the world, focused on advancing health. The QA Associate II is responsible for quality inspection and control on manufacturing production lines, ensuring compliance with quality specifications and reporting nonconformities.
Health CareHospitalMedicalMedical Device
Responsibilities
Independently perform and document final inspection of all production slides, vials, kits, and labels to established quality specifications, and make independent determination of acceptability for release
Independently perform incoming inspection of a wide variety of materials, analyze inspection results versus specifications, ensure correct sampling plans are used
Work with production associates to ensure materials utilized are released and correctly accounted for, line verification is performed prior to start of production, verify accuracy and completeness of documentation, and confirm equipment used meets designated specifications including calibration
Work with manufacturing personnel to accurately complete required Quality Control (QC) testing, documentation and determine correct disposition
Detect nonconforming conditions during inspection and accurately document each condition. Demonstrate a bias for action to determine scope of nonconforming conditions, and segregate nonconforming products to prevent further use
Perform basic lab support functions, including preparation of basic standards and reagents, PM, 5S, and cleaning and handling of hazardous waste as appropriate
Responsible for maintenance of retention samples, and electronic and physical storage of device history records
Must perform work in a safe manner adhering to gowning and PPE procedures
Participation in continuous improvement activities is required (e.g. kaizen)
Additional responsibilities as assigned by management
Qualification
Required
High School Diploma/GED with a minimum of 2 years related QC or manufacturing experience
General Proficiency in Microsoft Office
Demonstrated understanding of sampling techniques and inspection standards
Basic math skills and the ability to utilize Excel for basic calculations and graphing
Must be able to speak, read, and write English fluently as well as write technically and summarize information into data reports using Microsoft Word
Excellent attention to detail with a high degree of accuracy and the ability to work independently and in team situations
Excellent observation skills with a bias for 'corrective action' and improve work environment processes and procedures
Demonstrated ability to make critical decisions regarding product quality or quality system compliance
Ability to assess and articulate risk when evaluating a situation
Knowledge of basic validation, equipment calibration, and change requirements
Demonstrated understanding of the use of calibrated equipment
Proven capability to prioritize responsibilities and complete tasks on schedule
Must be able to work independently in a fast-paced manufacturing environment
Ability to stand for long periods of time
Ability to lift 25 lbs
Ability to do repetitive motion
Preferred
Basic knowledge of SAP is preferred
Experience working in an FDA regulated environment is highly desirable
Company
BD (Tissuemed Ltd)
Experts in bioadhesives: Tissuemed develops and markets adhesive films to prevent air, blood and fluid leaks encountered in surgery.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$0.05M2021-12-09Acquired
2015-06-01Grant· $0.05M
Recent News
2025-02-21
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