Quality Control Technician III

Dentsply Sirona, Inc • FL

64d

About The Position

This position is responsible for ensuring compliance of product being manufactured through product evaluation, testing and evaluation of production documentation for Device History Records (DHRs). This position has the responsibility to perform investigations, support and assist in the development of inspection procedures and test methods. This position is responsible to train QC Inspectors in both incoming and inprocess QC inspection Techniques. This position can be responsible for performing daily execution of quality inspection as it applies to both incoming goods and finished product and component goods in a timely manner.

Requirements

• High School Graduate; Some College Preferred.
• 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) required.
• Working knowledge of standard quality system requirements (ISO 13485, Medical Device Directive, Canadian Medical Device Regulation, MDSAP) preferred.
• 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.
• Must have excellent problem solving, time management, organizational, and interpersonal skills, with the ability to work independently.
• Ability to deal with a variety of variables in situations where limited information exists.
• Ability to manage conflict.
• Ability 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.
• Ability to multitask and prioritize work to meet defined timeliness requirements.
• Must be detailed oriented and well organized.

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.
• Performs completion of required paperwork, updated of associated product status, data entry and filing of associated documentation.
• Communicates quality related problems to Quality management, Operations and Supply Chain as required.
• Performs quality related software transactions in applicable ERP or other software applications.
• Performs other random quality inspection and testing activities as needed.
• Participates in failure investigations and determination of the source of defective products.
• Works with cross-functional team to solve and mitigate quality related problems.
• Ensures appropriate communication to Supply Chain, Quality Engineers, and management of quality related problems and drives corrective actions.
• Ensures that proper quality procedures, work instructions, and Inspection Procedures are in effect, updates as required.
• Responsible for training quality technicians and ensuring that all training records are up to date.
• Supports the non-conforming product process, including but not limited to timely control and communication with cross-functional team members.
• Supports QEs in the MRB meeting functions.
• Ensures all documents are completed fully and accurately and appropriately filed for tracking purposes.
• Responsible for interfacing with 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.
• 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.
• Quality Control support for all internal/external audit activities.
• Change agent for quality inspection techniques, including identifying nonvalue added activities.
• Assists in complaint investigations.
• Site internal auditor.
• Maintains Quarantine inventory.
• Catalogs retains and DHRs as assigned.
• Maintains up-to-date training compliance via LMS.
• Develops team culture to provide an optimum environment for employees’ growth and contribution.
• Follows all established health and safety policies.
• Commitment to Dentsply Sirona values and strategic goals.
• Other duties as assigned.

What This Job Offers

• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees