Quality Engineer
Becton Dickinson Medical Devices•San Antonio, TX
•Onsite
About The Position
The Quality Engineer will be responsible for executing and maintaining elements of the Quality Management System (QMS). The Quality Engineer will work on-site with multi-functional teams to implement, execute, maintain, and monitor the performance of quality system processes to support department and site goals.
Requirements
- Bachelor’s Degree in engineering or related field
- Working knowledge and/or experience in a regulated industry.
- Strong attention to detail and excellent organizational skills
- Able to work proactively and independently
- Able to multi-task and efficient in time management
- Excellent verbal and written communication skills
- Able to work in a team environment
- Proficient in Excel, Word, and other desktop/general business systems
Nice To Haves
- FDA and medical device experience
- Knowledgeable of FDA/ISO applicable guidance, regulations, and standards, including ISO 13485
Responsibilities
- Support the development, implementation, and ongoing maintenance of Quality Management System (QMS) processes to ensure full compliance with FDA 21 CFR 820 and ISO 13485 requirements
- Maintain and control documents used in the manufacturing of medical devices, including updating and distributing procedures
- Assist in managing electronic quality management system
- Maintain and control quality records for the site
- Administer the site training program by ensuring required training is assigned and training records are retained
- Perform comprehensive review of device history records (DHRs) and other relevant production documentation to ensure accuracy, completeness, and compliance with specifications and procedures
- Verify quality inspection results meet acceptance criteria
- Generate and approve product release documentation
- Support the customer complaints process, including complaint intake, evaluation, and reporting
- Analyze complaint data and report trends for significant complaint issues
- Support product risk management process
- Lead Corrective and Preventive Action investigations, action implementation, and effectiveness checks
- Conduct environmental monitoring and trend data
- Investigate non-conformances and execute dispositions
- Perform software validations for QMS impacting software
- Participate in the site’s internal and external audits
- Monitor quality system performance by compiling and presenting quality process performance data
- Coordinate and conduct information and training sessions, as necessary
- Identify and suggest continuous improvements to the quality management system
- Other duties and projects, as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
