Quality Technician I

Wellspect HealthCare; Sarasota (FL); On-site; USD 52,000 - 70,000; Full time

Job summary

Dentsply Sirona is seeking a Quality Inspector to ensure product quality through daily inspections of incoming, in-process, and finished goods. You will use precision equipment and generate Certificates of Conformity while collaborating with Quality, Operations, and Supply Chain to resolve issues.

The role requires 5+ years in manufacturing QA within a medical device environment, strong communications, and knowledge of US FDA/ISO quality systems. Equal opportunity employer.

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) required.
• Prior experience as an internal auditor preferred.
• Ability to assess risks and recommend contingency plans and strategies to mitigate risks.

Responsibilities

• Ensures timely completion and execution of daily quality inspection activities.
• Performs receiving, in-process and/or final inspection and testing activities for products to ensure quality.
• Utilizes electronic testing equipment such as Starrett and Keyence Video Measurement Systems.
• Develops product Certificates of Conformity for requesting Dentsfly Sirona entities.
• Performs completion of required paperwork, data entry and filing of documentation.
• Communicates quality related problems to Quality management, Operations and Supply Chain.
• Performs quality related software transactions in applicable ERP or other software applications.
• Participates in failure investigations and works with cross-functional teams to solve quality problems.
• Escalates new risks identified through inspections to QEs for evaluation and decisions.
• Supports internal audits and MRB meetings as needed.
• Maintains up-to-date training compliance via LMS.

Skills

Fluent English

Communication skills

Problem solving

Time management

Interpersonal skills

Organizational skills

Education

High School Graduate

Some College Preferred

Tools

Microsoft Dynamics AX

Microsoft Office

Job description

Select how often (in days) to receive an alert:

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands.

Dentsfly Sirona’s products provide innovative, high-quality, and effective solutions to advance patient care and deliver better and safer dental care. Dentsfly Sirona’s headquarter is located in Charlotte, North Carolina. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Visit www.dentsplysirona.com for more information about Dentsfly Sirona and its products.

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 Dentsfly 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.
• 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 Dentsfly Sirona values and strategic goals.
• Other duties as assigned.

Decision Rights

Accountable (Final Decision Rights)

Informed

• NA
• Quality Control IP Development
• Dentsfly Sirona Policies
• Dentsfly Sirona Orthodontics Strategies

Parameters for Success

Key Metric

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

Competencies and Key Skills and Experience

Typical Background

Dentsfly 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;

Equal Opportunity Employer: Dentsfly Sirona is an Equal Opportunity Employer. All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law.

Eligibility: All successful applicants must be eligible to work in the country the position is based.

Agencies: Please note that Dentsfly Sirona does not accept or respond to unsolicited requests or applications submitted by Recruitment Agencies/ Search Firms.

For California Residents: We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes). The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (i.e., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity). For additional details and questions, contact us at [e-mail] .