Government, Regulatory and Code, Quality Engineering
The Quality Engineer (QE) is responsible for managing technical files related to designs. The Quality Engineer will also provide and manage submissions for biocompatibility testing, CE marking and work instructions and procedures. This position also helps convey company culture and ensures it is maintained with fairness and respect to its employees. Additionally, the Quality Engineer will administrate the ECO and UniPoint software programs and assist with other projects, program initiatives and implementations related to the company QMS.
Essential Duties and Responsibilities:
Handles customer complaints by interacting with customers, documenting complaints, conducting investigations and issuing reports related to findings;
Work with QA and Engineering in generating risk analysis and FMEA reports;
Provide guidance and documentation for CE marking submissions.
Submit, monitor and document testing for various testing to outside labs (biocompatibility, sterilization, shelf life). Monitors status and implementations of Corrective and Preventive Action plans (CAPA), provide root cause analysis support and drive the implementation of corrective actions.
Interface with Engineering and Operations to ensure transfer to production of new products meeting all quality system requirements
Generate protocols and reports for Installation, Operational and Performance Qualification (IQ, OQ, PQ)
Participate in complaint investigations, failure analysis of returned products and production issues
Work with Manufacturing to coordinate and monitor production processes to ensure compliance to FDA QSR, ISO 13485
Participates in the Material Review Board, conducts investigations and documents meeting findings in UniPoint.
Write software validation protocols and reports for new and revised software applications
Write process validation protocols and reports for new and improved manufacturing processes
Assists senior QA personnel in Regulatory Authority inspections per Company’s policies and procedures
To accomplish all current and future tasks as appropriately assigned or requested
Minimum Education and Experience Required:
Four-year undergraduate degree or job knowledge equivalent to six years relevant work experience
Two years’ work experience in ISO 13485 preferably with exposure to FDA within the medical device industry
Certification, such as Quality Engineer, Quality Auditor, Six Sigma, or Quality Improvement Associate, is preferred
UniPoint, Microsoft Word, Excel, PowerPoint, Visio, Outlook
Autodesk AutoCAD, and SolidWorks helpful, but not required
Good administrative, interpersonal, and communication skills
Ability to work as an individual contributor or team player
Email resume to: firstname.lastname@example.org
About Smooth-Bor Plastics
Founded in 1971, Smooth-Bor Plastics is a leading innovator of plastic corrugated hose and tubing. Smooth-Bor® was the first to develop an all-plastic tube with a smooth inner bore to promote laminar flow. Today we maintain an intellectual property portfolio of patents and trademarks that began in 1973. Our most recent patents are still in force today in the United States and around the world, proving our commitment to continual research and development. We specialize in custom solutions for our customers and work diligently to provide products to suit their specific needs.