Quality Engineer

Responsibilities:

• Manage Change Control Requests as a quality resource
• Planning, coordinating, executing, documenting and performing pFMEA, validation studies, process capability studies and process improvements
• Participate (by reviewing and evaluating impact) in  disposition of non-conforming material decision-making process.
• Investigate and resolve customer complaints and CAPAs, implementing solutions
• Develop Quality Plans and work instructions, documenting procedures
• Support strategic projects aligned with Plant Operations, Engineering and Global Engineering 
• Conduct defect awareness training sessions
• Participate in internal/external audits
• Manage or support equipment calibration processes

Essential functions of the role:

• Knowledge and application of basic statistics and experimental design
• Good Communication skills, both written and oral
• Strong technical writing skills 
• Ability to train/facilitate
• Knowledge and implementation of medical device Quality System requirements (FDA and ISO) and Good Manufacturing Practice preferred
• Knowledge of Lean and Six Sigma principles 
• Proficient computer skills, including Microsoft Office Suite (Word, PowerPoint, Project, Access, and Excel).

Education/Work Experience Requirements:

• Minimum of 2 years of experience in Quality Engineering or equivalent industry disciplines
• Experience in medical device manufacturing regarding Quality System requirements per 21 CFR 820 and/or ISO 13485 preferred
• Degree in Engineering/Science Discipline or related study