Quality Technician III

Scope

• 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.

This job function directly ☒ indirectly ☐ affects product quality.

Reporting Relationships

Direct

                                                  Matrix

This Position Reports To:

Direct Reports to this role:

This Position Reports To:

Direct Reports to this role:

• Quality Manager

• N/A

• N/A

• N/A

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.
• 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.

Decision Rights

Accountable (Final Decision Rights)

Consulted

Informed

• NA

• Quality Control IP Development
• Inspection Techniques

• Dentsply Sirona Policies
• Dentsply Sirona Orthodontics Strategies

Parameters for Success

Key Metric

Financial Targets

• Training Timeliness, including On-Time Training Completion (self)

• NA

Competencies and Key Skills and Experience

Key Leadership Behaviors

Typical Background

Dentsply Sirona employees are expected to successfully demonstrate behaviors aligned with core values.  Those values include:

• We are one global team
• We live and breathe high performance and personal accountability
• We demonstrate passion for innovation and shape the dental industry
• We bring out the best in our people
• We act with uncompromising integrity
• We improve the practice of dentistry with an unrelenting commitment to customers

Educational Qualifications:

• High School Graduate
• Some College Preferred

Required Knowledge, Skills, and Abilities:

• 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;