We are seeking a Quality Engineer to support and implement systems in the areas of validation, advanced quality, risk management, change control, and design and development. The Quality Engineer will also support the development of and enforce internal systems and procedures to meet ISO standards, FDA quality system regulations, and other regulatory requirements. The Quality Engineer is responsible for developing and implementing inspection/validation techniques necessary to verify that products meet requirements at the earliest point in the production process, and specifies and implements new inspection equipment and instructs others in its proper use.
What you'll be doing:
Planning, executing, and reporting on equipment and process validation.
Assisting with training of quality and compliance concepts and best practices.
Working with the Quality team and cross-functional teams to conduct quality investigations, identify root causes, and present potential solutions.
Supporting product registration and surveillance activities by generating supporting technical documentation.
Planning and performing technical studies.
Creating and maintaining the company Risk Management program and working with internal team on risk mitigation strategies.
Creating and maintaining the company change management program.
Bachelor’s degree in quality, engineering and/or manufacturing fields preferred.
Must have 5+ years quality engineering experience in medical device manufacturing field with focus on design and production.
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 preferred.
Knowledge of design control processes.
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.
What we offer:
Full benefits (the big three: medical, dental, vision)
Paid vacation, paid sick time, and paid holidays
A 401K retirement plan with matching
ClearCorrect aligners discount