2025-08-16
Straumann Group
Other
/yr
employee
contract
Round Rock
Texas
78664
United States
Straumann Group
Position Title: Quality Engineer
Location/s: Round Rock (TX), United States
Job Category: Quality Assurance
Company: CCUS - Clear Correct LLC
Description:
#ChangeMakers
Ready to make an impact?
We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.
We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition. From the first Dental Implant in 1974 to the latest Digital Solution – we do things differently than others
We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful “can-do” attitude.
#WeChangeDentistry every day. Be part of it.
Summary of position
Supports and implements systems in the areas of validation, advanced quality, risk management, change control, and design and development. Supports the development of and enforces internal systems and procedures to meet ISO standards, FDA quality system regulations, and other regulatory requirements. Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process.
Essential functions and duties
• Support technology transfer of processes / articles by providing complete, accurate, and efficient quality plans; this includes sampling points and plans, process control requirements, test methods, measurement technique and evaluation criteria throughout the manufacturing process
• Perform product and process evaluations to identify areas for improvement. Recommend solutions to identified problems; Implement approved changes using sound quality engineering principles and fully document them in compliance with QSR and ISO standards
• At times, support manufacturing by analyzing defect conditions as necessary to implement corrective actions and perform day-to-day troubleshooting and resolve immediate problems on the manufacturing floor
• Lead cross functional projects as assigned
• Perform process capability studies, design experiments, risk analysis, gage repeatability and reproducibility studies, statistical evaluations as necessary to increase control and lower total quality costs
• Act as Quality representative for NCMR’s, ECO’s, CAPA’s, etc.as required
• Participate in validation teams, PFMEA’s, investigations, etc. as required
• Works with cross functional teams to implement changes in accordance with internal procedures.
• Assists with training of quality and compliance concepts and best practices.
• Work with Quality team and cross-functional teams to conduct quality investigations, identify root causes, and present potential solutions.
• Support product registration and surveillance activities by generating supporting technical documentation.
• Plans and performs technical studies, including biocompatibility studies.
• Collects and analyzes quality data.
• Supports the company Risk Management and Biocompatibility program and works with internal team on risk mitigation strategies.
• Follows safety rules and maintains personal safety and the safety of others, including maintaining a clean and safe work area.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. A reasonable accommodation may be made to ensure individuals with disabilities are able to perform the essential functions of the role.
• Bachelor’s degree in quality, engineering and/or manufacturing fields required
• Must have 3+ years quality engineering experience in medical device manufacturing field with focus on design and production
• Ability to work with multidisciplinary teams to execute projects, investigations, and training
• Demonstrated ability to plan and work to robust timelines
• Experience in planning, execution and reporting of equipment and process validations
• Excellent understanding of quality principles and good documentation practices
• Familiarity with US and International medical device regulations
• Must be familiar with and competent in conducting and managing Risk Management plans and summaries
• Familiarity with ISO 14971 and 10993 preferred
• Knowledge of design control processes
• Experience in investigation techniques and problem solving
• Must be able to utilize basic quality tools including RCA, Fishbone analysis, SPCs, FMEA, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts
• Must be able to produce technical documents, testing and validation plans, IQ/OQ/PQ protocols and formal procedures
• Six Sigma/Lean Manufacturing skills recommended
• Must have excellent written communication skills
• Must have basic computer skills including Microsoft Office
Additional Information:
Whether you’re looking to build your career, improve your health, or brighten your SMILE, we offer generous benefits to help you achieve your goals.
Please understand that we do not need external support by recruiting agencies and consultants to fill this vacancy. Thank you for respecting this.
Videos To Watch:
https://youtu.be/3lq5BLAvIdQ
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
Employment Type: Full Time
Alternative Locations: United States : Round Rock (TX)
Travel Percentage: 0%
Requisition ID: 18991
PI277347885
