Overview
Director Quality Management II – Quality Management Jobs in New Braunfels, TX at Christus Health
Position Summary
This position is responsible for performing tasks directly related quality assurance and control. This role involves performing visual and dimensional measurements of molded components, sub-assemblies, and final product. Measurements also include functional testing and assessment of physical attributes in some cases. The Mechanical Inspector will also create measurement inspection plans and programs for molded components and participate in validation testing using optical and contact measuring machines. This position is responsible to ensure that medical devices and components are measured/inspected with the highest quality possible. Provide support for NCMRs, investigations, and other duties as needed. The ideal candidate will possess strong attention to detail, technical expertise in metrology, and a commitment to maintaining high-quality standards in a fast-paced manufacturing environment.
Essential Duties & Responsibilities
Read, interpret, and understand drawings and specifications
Use hand gauges for inspections (calipers, micrometers, height/depth gauges, etc.)
Use measurement machines such as OGP SmartScope, Zeiss O-Inspect, and similar machines for optical and contact measurement via a computer interface
Product sampling and subsequent part inspection according to specifications
Report and generate material non-conformance lot reports (NCMR’s)
Recognize and communicate deviations from accepted practices in all areas of quality review
Follow cGMP
Create robust inspection plans and/or routines
Perform First Article and Validation Inspections
Perform Gauge R&R when needed
Using SPC software analyze statistical data
Work on special projects as they arise
Knowledge, Skills & Qualifications
Strong knowledge of Plastic Processing
cGMP knowledge
Basic math skills
Basic computer knowledge
Strong written and verbal communication skills
Familiarity with ASTM Standards a plus
Familiarity with ISO 9001, 13485 and Medical Manufacturing Environments a plus
Must be detail oriented and follow instructions and specification meticulously
Knowledge of SPC software, preferably Prolink QC-Calc
Ability to program smart scope software, preferably QVI Zone 3, Measuremind3D and Zeiss Calypso
Understanding of measurement theory and practices including geometric dimensioning and tolerancing (GD&T) per ASME Y14.5
Education and Experience
High School diploma or equivalent
Minimum 2 years of experience performing measurement inspections in manufacturing environment
Preferred Qualifications
2+ years of experience creating automated routines with Measuremind, Zone 3, Calypso, or similar software
4+ years of experience performing measurement inspections in an FDA regulated manufacturing environment, preferably medical device components
Minimum Qualifications
Must be at least 18 years of age
Travel Requirements
Typically requires travel less than 5% of the time
Physical Requirements and Work Environment
Work is generally performed in a clean room environment
While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating
Operator is required to use computer, touch screen, or pen and paper to enter data
Must be able to occasionally move and lift objects of up to 25 lbs
Title: Director Quality Management II – Quality Management
Company: Christus Health
Location: New Braunfels, TX
