Permanent position: Immediate direct-hire opening for a quality engineer in the greater Orlando area. This is a medical device manufacturing company. They would like someone with at least 2-3 years of professional experience specifically performing quality engineering in a manufacturing environment for medical devices. The ideal candidate will have 3 years of professional experience and a working knowledge of or practical experience with ISO 9001/ISO 13485. A Bachelors of Science in Engineering (or related field) is required. This position will report to the Quality Manager, Quality Director and Quality VP.
Relocation assistance may be considered for the right candidate.
Responsibilities for the Quality Engineer
- Able to apply and analyze situations related to regulatory, documentation, design, risk analysis, audit, corrective action, product development, pre and post market, and supplier management requirements
- Able to participate, implement, or understand new strategies, processes and policies as it relates to good manufacturing practice requirements, validation, design input, rework, audits, complaint, component and control
- Able to evaluate and implement methods, definitions, and principles as it relates to their functional area of quality and is able to transfer and share that knowledge and experience to newer members of the team
- Determine the appropriate standard quantitative methods such metrology, data analysis, statistical process control, etc. across a spectrum of business environments to facilitate process analysis and improvements
- Previous experience participating in a quality audit process including, preparation, reporting results and follow-up
- Able to review and act on the company policy, procedures and documentation to their functional area as deemed necessary by governmental changes
Requirements for the Quality Engineer
- BS Degree in Engineering, Science or Quality is required. MS Degree preferred.
- 3+ years of experience working in a progressive manufacturing operations or quality envrionment
- Working toward Certified Quality Engineer and/or Six Sigma, Black Belt, LEAN, Quality Auditing etc.
- Experience and understanding in two or more cross functional areas (regulatory, documentation, design, risk analysis, audit, corrective action, product development, pre and post market, and supplier management).
- Working knowledge and practical experience of FDA's QSR and ISO 9001 or ISO 13485 quality systems
- Competitive salary + company sponsored benefits and PTO