Quality Engineer

Straumann Group
Position Title: Quality Engineer
Location/s: Round Rock (TX), United States
Job Category: Quality Assurance
Company: CCUS - Clear Correct LLC

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.

Supports and implements systems in the areas of validation, advanced quality, risk management, change control, and design and development. Supports the development and enforcement of internal systems and procedures to meet the local Quality Management System, ISO standards, FDA quality system regulation, and other regulatory requirements. Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process.

Specifies and implements new inspection equipment and instructs others in its proper use.

• Plans, executes, and reports on equipment and process validation.
• Assists with training on 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.
• Supports Treatment Planning teams in planning and execution of audits by external partners, regulatory authorities and/or their representatives.
• Creates and maintains the Risk Management program and works with internal team on risk mitigation strategies.
• Creates and maintains the change management program.
• Participates in the development, implementation, and reporting of metrics of interest to local operations, management, and external partners.
• Follows safety rules and maintains personal safety and the safety of others, including maintaining a clean and safe work area.
• Accurately records and reports of information as required.
• Follows employee policy within the company.

• Attends Quality and other meetings as required.
• Participates in additional training relevant to this position.
• Other duties may be assigned, directed or requested.

Qualifications:

• Must be proficient in English spoken and written language.
• Bachelor's degree in quality, engineering and/or manufacturing fields preferred.
• Must have 3+ years quality control or quality assurance experience in the medical device manufacturing field.
• Ability to work with multidisciplinary teams across multiple countries 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 and registrations.
• Must be familiar with, and competent in, conducting and managing Risk Management plans and summaries. Familiarity with ISO 13485 preferred.
• Knowledge of design control processes.
• Experience with managing non-conformances and CAPA.
• Front and back room audit experience.
• 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 preferred.
• Must have excellent written communication skills.
• Must have basic computer skills (Microsoft Office).

• Resourceful and Hands‑on:
  An energetic, resourceful, agile, and hands‑on individual who operates effectively with minimum direction and pursues objectives and works to deliver against goals…