Quality Technician III

Key Responsibilities

• Ensures timely completion and execution of daily quality inspection activities.
• Performs receiving, in-process and/or final inspection and testing activities for both distributed and manufactured products as required to ensure product quality.
• Utilizes electronic testing equipment such as Starrett and Keyence Video Measurement Systems.
• Develops product Certificates of Conformity for requesting Dentsply Sirona entities.
• Communicates quality related problems to Quality management, Operations and Supply Chain as required.
• Supports the non-conforming product process, including but not limited to timely control and communication with cross-functional team members.
• Maintains Quarantine inventory.
• Maintains up-to-date training compliance via LMS;
• Supports QEs in the MRB meeting functions.
• Documents quality data using good documentation practices both manually and electronically, ensuring all quality data is in a retrievable state to support continuous improvement activities.
• Escalates any new, unknown risk or hazards identified through inspections to QEs for further evaluation and decisions.
• Change agent for quality inspection techniques, including identifying nonvalue added activities.
• Affords assistance in complaint investigations.
• Serves as a Site internal auditor.
• Supports QEs in the MRB meeting functions.
• Ensures all documents are completed fully and accurately and appropriately filed for tracking purposes.
• Supports Procurement to ensure timely return of NC Materials/Products to suppliers.
• Interacts with cross functional teams to obtain additional information as needed to ensure completeness of all required appropriate documentation.

Qualifications

• 5+ years of manufacturing, quality assurance/control in a medical device environment.
• Fluent English speaking and writing skills, Knowledge of Spanish is a plus.
• Excellent communication and influence skills with the ability to work interactively with off-site resources.
• Working knowledge of US medical device regulations (21 CFR Parts 820, 803, and 806).
• Working knowledge of standard quality system requirements (ISO 13485, Medical Device Directive, Canadian Medical Device Regulation, MDSAP).
• Prior experience as an internal auditor preferred.
• Ability to assess risks, and where appropriate, recommend contingency plans and strategies to mitigate risks.
• Strong problem-solving skills and ability to make firm decisions.
• Highly motivated self-starter with the ability to function in a fast-paced team-oriented environment with minimal supervision.
• Able to manage conflict.
• Able to articulate thoughts and ideas effectively through both written and oral communication.
• Proficient in Microsoft Office software, including Outlook, Word, Excel, and PowerPoint, as required.
• Microsoft Dynamics AX knowledge preferred.
• Ability to perform effective investigational and root cause activities.
• Able to multitask and prioritize work to meet defined timeliness requirements.
• Must be detailed oriented and well organized.