Aesculap Implant Systems
Quality Control Test Technician
US-PA-Breinigsville
Job ID: 2021-18977
Type: Regular Full-Time
# of Openings: 1
Category: Manufacturing
Distribution Warehouse AIS
Overview
Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives.
Responsibilities
Position Summary:
The Quality Control Test Technician supports the Quality Assurance function by performing customized inspections and testing on incoming components, raw materials, and purchased finished goods. Additionally, the Quality Control Test Technician works with Manufacturing/Prototype Development Department/Product Marketing to conduct in process and finished product inspections, completes reports, analyzes data and communicates to Product managers, Manufacturing/Prototype Shop, Quality and R&D management on the inspection and test status of product. Responsible for the maintenance of calibration system documentation on all inspection tools. Position requires thorough knowledge of products and production process along with testing, inspection, statistical control and design procedures.
Responsibilities: Essential Duties
- Interprets engineering drawings, schematic drawings and conferrers with engineering staff and management to create inspection techniques that determine Quality standards for devices.
- Determines priority for daily inspection activities with limited input from the QA leadership and Quality Engineers.
- Creates and performs custom inspections and testing on incoming components, raw materials, and purchased finished goods to applicable design standards and specifications.
- Works with Manufacturing/Prototype Development Department to develop and conduct in process and finished product mechanical as well as performance inspections.
- With R&D guidance creates test plans for incoming, in process and final inspections and compiles inspection criteria.
- Works with product managers to create and perform Product Evaluations.
- Documents inspection results by completing reports and logs; summarizes re-work and inputs quality data into databases as appropriate.
- Prepares graphs or charts of data and performs data entry into computer program for analysis.
- Maintains material certifications from receiving inspection activities and maintains product identification and traceability.
- Identifies, documents, and initiates Nonconforming Material Reports (NCR's) for resolution as required.
- Sets up and performs destructive and nondestructive tests on materials, parts, or products to measure performance, life, or material characteristics.
- Monitors calibration schedules for all inspection, measuring, and test, equipment at TekPark to include documentation & resolution of Out of Tolerance nonconformances.
- Performs special projects such as first article inspections, measurement analysis, fit to mating part analysis, design verification testing, gage repeatability studies (R&R) and equipment validations.
- Reviews, approves, and applies labels to packaging in preparation for product shipments.
- Must comply with applicable ISO and FDA regulations as stated in Quality Manual.
- Must embody the Company’s Vision, Mission and Values.
- Other duties may be assigned
Secondary or peripheral job functions:
Supervisory Responsibilities:
Expertise: Knowledge & Skills
- Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.
- Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
- Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Qualifications
Expertise: Qualifications-Experience/Training/Education/Etc
Required:
- Associates Degree in a technical field or equivalent on the job experience.
- Requires minimum of 1 years Quality Control with mechanical inspection or related experience. CQT certification a plus.
- Prior Machine shop inspection experience
- Previous medical device manufacturing experience and a working knowledge of FDA Quality System Regulation and ISO 13485 preferred.
Special Requirements:
- High mechanical aptitude.
- This position requires knowledge of Quality inspection methods, good statistical analytic and technical skills.
- Must have experience using Optical Comparators, Coordinate Measuring machines, calipers, micrometers, hard gauging and other applicable inspection tools.
- Must be capable of reading and interpreting engineering drawings.
- Must be detail-oriented and have good problem solving skills.
- Must have good written and verbal communication skills.
- Must follow standard operating procedures and comply with the company’s Quality Manual.
- Must be proficient with email systems, Microsoft Excel and Word.
- Coordinate Measurement Machine (CMM) programming experience a plus.
- CAD engineering software experience a plus.
- This position requires the handling of instruments that may have been contaminated by blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.
- May occasionally need to work overtime or on weekends.
Desired:
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
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