Quality Engineer - Retractable Technologies, Inc.
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Button Quality Engineer Location: Little Elm, TX Department: Quality Assurance Reports To: Quality Assurance Manager Salary: $70,000 - $90,000
Job Description
Develops and implements quality control systems, inspects and tests products, and analyzes data to ensure products meet safety and quality standards such as ISO13485, Medical Device Regulation 2017/745 (EU MDR), 93/42/EEC, MSDAP and the US Code of Federal Regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The essential duties and responsibilities include the following.
• Review and Analysis • Test Planning • Automation • Defect Management • Documentation • CAPA • Utilize the Quality System to ensure CAPA system is successful and compliant • Document Control • Responsible for Document Control of existing procedures and records, ensuring compliance with all applicable Standards and Requirements • Auditing • Internal and supplier audit training for EUMDR and ISO 13485 • Lot Release • Review and ensure compliance in releasing and verifying DHR • Lot release • Data Analysis: Use statistical analysis and various software to analyze complex data and make data-driven decisions • Provides QA support during third party audits • Identifies deadlines and implements methods to comply with responsibilities in a timely fashion • Ability to get along with others, follows directions, and works well under stressful conditions • Responsible for following company policies and procedures, including but not limited to, Quality System Regulations, safety/housekeeping, and Quality Management System.
SUPERVISORY RESPONSIBILITIES
None
EDUCATION and/or EXPERIENCE
Bachelor's degree required. 2 - 5 years' related work experience. Medical device experience and customer service experience required. Six Sigma black belt, preferred. Must understand and know how to navigate a CAPA through the Quality System. Working knowledge of ISO 13485, 21 CFR Part 820.100. Experience in computer/database applications, proficiency in Microsoft Outlook, Word, and Excel.
INTELLECTUAL SKILLS
The intellectual skills described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Ability to speak, read and write English, bilingual in Spanish a plus • Ability to work with minimal supervision • Ability to be proactive, take initiative to be productive and recognize and establish priorities • Excellent written and verbal communication skills • Ability to communicate effectively with other departments as well as all levels of management • Solid analytical and problem-solving skills • Demonstrates continuous improvement and consistent metrics to achieve business results and quality output • Strong project management and organizational skills • Excellent attention to detail, resourceful, self-reliant, self-motivated, and confident • Ability to multi-task and adjust to frequent changes • Ability to be tactful, discreet and handle confidential info appropriately
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hands, stoop and bend, reach, climb stairs • The employee must occasionally lift and/or move up to 20 pounds • Use of vision is required for document/report inspection/analysis and visual observation of a computer monitor • Use of hearing and speech are necessary for telephone work • Ability to operate standard business and office equipment such as adding machines, copiers, calculators, typewriters, fax machines, etc.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• The noise level in the work environment is usually moderate • Lighting is usually fluorescent • Heating/Air Conditioning/Ventilation is usually adequate to accommodate the general office population • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
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Application Instructions
First Name Last Name Email Where are you located? Position of Interest Upload Resume What is your education history with year of graduation? Please list your recent job and 3 other jobs that lasted more than 1 year. List 3 primary responsibilities for each position. Most Recent Job Previous Job 1 Previous Job 2 Previous Job 3 What are your hobbies (community activities, sports, free time, etc)? Write 50-100 words on why the prevention of the reuse of syringes and accidental needlestick injuries are important. Submit Application
Company Information
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Contact Us
511 Lobo Ln Little Elm, TX 75068 (972) 294-1010 rtiservice@retractable.com
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