Quality Engineer I

Dentsply Sirona, Inc

26d

About The Position

The primary job responsibility for the Quality Engineer I is to ensure compliance of the Quality Assurance and manufacturing process(es) while directly supporting overall quality initiatives. This includes but not limited to: Overseeing the day-to-day functions of the Sarasota site Calibration system Conducting Complaint investigations Maintaining and Programing electronic measurement equipment. Development and execution of test methods, protocols, and DOEs and performing MINITAB analysis of results. Ensuring conformance of all phases of a products lifecycle in a world-wide regulated medical device environment. Implementing/improving statistical process control techniques. NC/CAPA Complaint Investigation and MRB participation, as applicable. Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative of Quality group on projects.

Requirements

Bachelor Degree in Science, Engineering or similar field, or equivalent combination of education and experience is required.
Minimum 1 year full time experience in a Quality Engineering role is preferred, but advanced degrees and/or internship experience will also be considered.
General knowledge of FDA, cGMP and ISO Standards/regulations.
General knowledge of upstream process development and validations, including protocol development.
Able to read and interpret mechanical drawings
Test method development and documentation
General knowledge of Six Sigma methodology, SPC techniques and MINITAB data analysis
Proficient in Microsoft Office software including Outlook, Word, Excel, Power Point and Visio.
Organization and analytical skills
General knowledge vision measurement equipment, and calibration procedures
Ability to work in a cross-functional team setting
Detailed oriented, high energy, self-starter, who exercises sound judgment and deliver against company business goals and objectives
Excellent communication, and presentation skills, both orally and written.
Results oriented change agent.
Ability to read, write and communicate in English.

Nice To Haves

One (1) year of practical medical device manufacturing experience is preferred.
Ability to speak Spanish a plus.

Responsibilities

Works closely with Manufacturing Engineering.
Active team member during risk assessment activities and updates associated pFMEAs as required.
Supports the development of test methods, writes protocols, performs DOEs, executes testing, and performs MINITAB analysis of results, evaluates process stability and capability, and prepares test reports.
Performs essential measurements, testing, analysis, and keeps records using Good Documentation Practices and communicates to team about findings.
Supports process validation activities associated with both new and/or changed products.
Supports reliability analysis, problem solving and continuous improvement activities.
Maintains compliance of the Sarasota site Calibration system and reports on calibration metrics.
Site Administrator to ensure compliance and control of all measuring and test equipment in accordance with calibration and verification process.
Ensures all new test equipment is calibrated and entered into calibration tracking system.
Acts as subject matter expert and programmer for the Visual Measurement Systems utilized within the facility.
Independently investigates complaints in accordance with applicable medical device regulations and internal Quality Management System (QMS) processes/procedures, while ensuring investigations are completed in accordance with the defined timeframes.
Maintains compliance of the Sarasota site Non-conformance system, ensuring all product non-conformance documentation is complete, timely and in accordance with established procedures, regulations and requirements
Contributes in preparing and updating quality plans, as required.
Assists in preparation and updates of manufacturing procedure documentation, and quality procedure documentation.
Active CAPA owner, conducting root cause investigations and providing appropriate abatement solutions to prevent reoccurrence.
Maintains NC / CAPA documentation in a timely manner.
Participates in process improvement activities within the business to drive consumer satisfaction levels and business productivity.
Supports the implementation of new/updated manufacturing processes.
Drives a culture of continuous improvement and identifies actions to eliminate process variation.
Participates in assessment teams in applying quantitative tools to identify the current state from which improvement opportunities exist.
Communicates project progress, capture cost savings, consumer satisfaction, or other appropriate business productivity metrics to direct supervisor.
Documents data obtained during all quality activities using good documentation practices.
Communicates significant issues or developments identified during quality activities and provides recommended process improvements to direct supervisor.
Identifies and proposes continuous improvement opportunities to direct supervisor.
Initiates corrective and preventive action (CAPA) plans with root cause analyses as needed.
May participate in external customer, quality systems and regulatory agency audits/inspections as required.
May participate in internal auditing program as qualified internal auditor.
Other duties as approved by manager.